LIST OF APPROVED DRUG FROM 01.01.2009 TO 31.12.2009

S. NO.

DRUG NAME

INDICATION

APPROVAL DATE

1.

Zoledronic Acid Injection 5mg/100ml (Addl. Indication)

For the treatement of osteoporosis in post-menopausal women and in men who are at increased risk of fracture,including those with a recent low-trauma hip fracture.

07.01.09

2.

Misoprostol Tablet 600mcg

Addl. Strength

09.01.09

3.

Acebrophylline Syrup 10mg/ ml

For the treatement of adult patients with chronic obstructive pulmonary disease(COPD) and bronchial asthma.

09.01.09

4.

Selamectin Tropical solution (for verterinary use.) 60mg/120mg per ml

(I) For the treatement and lasting prevention of flea infestations,treatment and control of flea allergy dermatitis, prevention of heartworm disease,treatement and prevention of ear mites in dogs and cats;

(II) For the treatement and prevention of sarcoptic mange,roundworms and for control of tick infestations in dogs.

09.01.09

5.

Methylcobalamin1500mcg + Calcium 200mg + Calcitriol 0.25mcg + Folic Acid1.5mg + Pyridoxine3mg Capsules

For the treatment of vitamin deficiency states in adults

14.01.09

6.

Metoprolol tartrate tablets 50 mg (Addl. Indication)

Adjunct to the treatement of Hyperthyroidism

14.01.09

7.

Cinacalet (as HCl) Tablet 30/60/90mg

For the treatment of secondary hyper parathyroidism in patients with chronic kidney diseases (CKD) on dialysis and for hypercalcemia in patients with parathyroid carcinoma

14.01.09

8.

Mycophenolate mofetil Capsules 250mg, Tablets 500mg, Oral suspension 200mg/ml (addl. Indication)

For the prophylaxis of acute organ rejection in patients recieving allogenic hepatic transplantation.

23.01.09

9.

Liquid Paraffin1.25ml + Milk of Magnesia 3.75ml + Sodium Picosulphate 3.33mg per 5ml

For symptomatic treatment of constipation in adults

29.01.09

10.

Ranolazine 1000mg ER Tabs (Additional Strength)

Same as approved

31.01.09

11.

Hyaluronic acid (cross linked) Pre-filled syringe 18mg/0.6ml and 24mg/0.8ml

For intradermal implantation and facial soft tissue augmentation

31.01.09

12.

Caspofungin acetate Injection (Addl. Indication)

For use in following: (I) Empirical therapy for presumed fungal infections in febrile neutropenic patients.

(II) Treatment of Candidemia and the following Candida infections: Intra-abdominal abscesses, Peritonitis and Pleural space infections.

(III) Treatment of Esophageal Candidiasis.

(IV) Treatment of invasive Aspergillosis in patients who are refractory to or intolerant of other therapies (i.e, amphotericin B, lipid formulations of amphotericin B, and/or itraconazole)

31.01.09

13.

Micafungin ( as sodium) Powder for solution for infusion 50mg / vial

For the treatment of patients with candidemia, acute disseminated candidiasis, candida peritonitis, abscess and esophageal candidiasis. For the prophylaxis of Candida infection in patients undergoing hematopoietic stem cell transplantation (HSCT)

31.01.09

14.

Loteprednol Etabonate Nasal spray 0.1% w/v

For prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis.

31.01.09

15.

Rasagiline (as mesylate ) Tablet 0.5mg/1mg

For the tratment of signs and symptoms of idiopathic Parkinson's disease as intial monotherapy and as an addition to levodopa.

31.01.09

16.

Nicotine Polacrilex Gum 2mg & 4mg (Addl. Indication)

To reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco.

03.02.09

17.

Closantel Injection100mg/ ml (for verterinary use.)

For the infestation of trematodes, nematodes, cestodes and arthropods of domestic animals, including milch and other food producing animals.

05.02.09

18.

Lornoxicam 4mg + Paracetamol 500mg film coated tablets

For the short term use in acute painful & inflammatory conditions in adults

05.02.09

19.

Cetrimide15% w/v + Chlorhexidine Gluconate 7.5% v/v + Isopropyl Alcohol 7.5% v/v Concentrate Solution

For cleansing of physically contaminated wounds and for pre-operative disinfection

09.02.09

20.

Ketoconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) Solution

For the treatment of dandruff

09.02.09

21.

Doripenem (as monohydrate) Injection 250mg/500mg

For the treatment of nosocomial pneumonia in adults.

16.02.09

22.

Halobetasol Scalp Approved 0.05% w/v

For the relief of inflammatory and puritic manifestation of corticosteroid respensive dermatosis

18.02.09

23.

Nicotine (as Polacrilex) Lozenges 2mg & 4mg

To reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and guthka containing tobacco.

18.02.09

24.

Tranexamic Acid Tab SR 750mg

For the treatment of menorrhagia

20.02.09

25.

Betahistine Mesilate Tablet 6mg/12mg

For the treatment of dizziness and feeling of dizziness resulting from Meniere's disease, Meniere's syndrome and vertigo.

20.02.09

26.

Abatacept Injection 250mg/vial (Addl. Indication)

In moderately to severly active rheumatoid arithritis in adults and may be used as monotherapy or concomitantly with DMARD's other than TNF antagonists

20.02.09

27.

Anidulafungin Injection (Lyophilized powder) 50mg/100mg per vial

For the treatment of invasive candidiasis including candidemia and esophageal candidiasis in adult patients.

23.02.09

28.

Hydroquinone 2%+ Tretinoin 0.05% + Hydrocortisone1%Cream

For the treatment of patients with skin hyperpigmentation

23.02.09

29.

Doxyphylline 400 mg + Terbutaline 5mg tablets

For the treatment of asthma and chronic obstructive pulmonary disease in adult patients only

23.02.09

30.

Hydroquinone 20mg + Tretinoin 0.25mg + Fluocinolone Acetonide 0.1mg per gm Cream

For the treatment of melasma of face in adults

23.02.09

31.

Ketoconazole 2% + Zinc Pyrithone 1% Lotion

For the treatment of pityriasis and dandruff of the scalp

23.02.09

32.

Lamivudine 30mg + Zidovudine 60mg + Nevirapine 50mg Oral Suspension (Tablets for oral Suspension)

For the treatment of HIV patients

23.02.09

33.

Glibenclamide 5mg + Pioglitazone 15mg + Metformin500mg film coated tablets

As 3rd line treatment of type II diabetes mellitus when diet, exercise and the single agents and the second line therapy with two drugs do not result in adequate glycemic control

23.02.09

34.

Aceclofenac 100mg + Tizanidine 2mg film coated tablets

For the treatment of acute low back pain in adult patients only

23.02.09

35.

Octinoxate 7.5% + Avobenzone 3% + Oxybenzone 3% + Titanium dioxide 2% lotion

As sunscreen lotion for prevention of sunburn skin

23.02.09

36.

Cetrizine 5/10mg + Ambroxol 30mg per 5ml syrup

For the symptomatic relief of productive cough associated with allergic rhinitis, when both anti-histamine and mucolytic agents are desired

23.02.09

37.

Lidocaine Lozenges 200/300mg

For single agent anesthesia in upper gastro intestinal endoscopy.

26.02.09

38.

Calamine 8% + Liquid Paraffin10% lotion

As antipruritic and smoothening agent

26.02.09

39.

Nifedipine 0.3% + Lidocaine1.5% cream

For the treatment of anal fissures

26.02.09

40.

Quinapril 20mg + HCTZ 25mg film coated tablet

For the treatment of mild to moderate hypertension in adult patients (in whom combination therapy is appropriate) who have been stabilized on the individual components given in the same proportion

26.02.09

41.

Levodopa 100/100/250 + Carbidopa 10/25/25mg mouth dissolving tablet

For the symptomatic symptoms of idiopathic Parkinson's Disease

04.03.09

42.

Paliperidone ER Tablets 1.5mg

Addl. Strength

04.03.09

43.

Losartan 100mg+ HCTZ 25 mg tablet

Additional higher strength

16.03.09

44.

Darunavir(as ethanolate) Tablet 300mg

For the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment experienced adult patients, such as those patients with HIV-1 strains resistant to more than one protease inhibitor when co-administered with 100mg ritonavir, and with other antiretroviral agents.

19.03.09

45.

Ropivacaine HCl Inj.2/5/7.5/10mg

For the production of local or regional anasthesia for surgery and for acute pain management.

19.03.09

46.

Butaphosphan 100g + Methyl Hydroxybenzoate 1gm + Cyanocobalamin50 gm Oral powder (Veterinary Drug)

As vitamin and phosphorous supplement for livestock, shirmp and fish.

19.03.09

47.

Fluticasone furoate Nasal spray 27.5mcg per spray

For the treatment of symptoms of allergic rhinitis.

19.03.09

48.

Octinoxate 7.5% + Avobenzone 2% + Oxybenzone 3% + Octocrylene 3%+ Zinc Oxide 2% lotion

A sunscreen lotion for prevention of sunburn skin

19.03.09

49.

Omeprazole 20/40mg + Sodium Bicarbonate 600mg+ Magnesium Hydroxide 700mg sachet

Additional Strength

19.03.09

50.

Ambroxol 30mg + Levo salbutamol 1mg+ Guiphenesin 50mg /5ml syrup

For the symptomatic relief of bronchospasm in bronchial asthma & chronic bronchitis

19.03.09

51.

Montelucast 4 mg+ Levocetrizine 2.5 mg tablet

Additional lower paedriatric dose

19.03.09

52.

Surgical Sealant

To be indicated for use in sealing suture lines along arterial and venous reconstructions.

26.03.09

53.

Lidocaine Patch 700mg in aqueous base. (50 mg per gram adhesive)

For the relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.

26.03.09

54.

Bimatoprost Opthalmic solution 0.03%

For the treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.

30.03.09

55.

Trabectedin powder for concentrate for solution for infusion 1 mg/ vial

For the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to recieve these agents.

30.03.09

56.

Acebrophylline Syrup 10mg/ml (Additional Indication)

For the treatment of children (age 6to 12years) with chronic obstructive pulmonary disease(COPD) and bronchial asthma.

30.03.09

57.

Mesalamine PR Tablets 1.2gm

For the induction of remission in patients with active, mild to moderate ulcerative colitis.

30.03.09

58.

Mycophenolate Mofetil Tablets 750mg Additional Strength

Same as approved

31.03.09

59.

Ketorolac Tromethamine Gel 2%w/w

For the treatment of muscle, joint and post-traumatic stress.

31.03.09

60.

Theophylline 400mg SR + Montelukast 10mg Tablet

For the treatment of patients with bronchial asthma

31.03.09

61.

Hyaluronic Acid Sodium Salt 0.2 gm + Silver Sulfadiazine 1.0 gm/25 gm tube
Hyaluronic Acid Sodium Salt 50 mg + Silver Sulfadiazine 1.0 gm/ 100 gm gauze pads impregneted with cream.

For the treatment of wound of different etiology

31.03.09

62.

Telmisartan 80mg + Amlodipine 5mg tablet

Additional higher strength

31.03.09

63.

Hyaluronic Acid Sodium Salt

(i) Each 15gm tube contains: Hyaluronic Acid Sodium Salt 0.2gm/100gm

(ii) Sterile Gauze Pads impregnated with cream: Each gauze pad contains Hyaluronic Acid Sodium Salt 50/100mg

For the treatment of wound of different etiology

31.03.09

64.   

Abatacept Injection 250mg/vial  (additional indication)

For reducing signs and symptoms of moderately to severly active polyarticular juvenile idiopathic arthritis/juvenile rheumatoid arthritis in pediatric patients 6 years of age and older who have had an inadequate response to one or more DMARD's such as MTX

10.04.09

65.   

Cetrizine 10 mg + Ambroxol 75 mg SR Tablet

For symptomatic relief of productive cough associated with allergic rhinitis, when both anti-histamine and mucolytic agents are desired

13.04.2009

66.   

Ciclesonide 200mcg + Formoterol 6mcg + Tiotropium 9mcg MDI

Indicated as third line treatment of severe cases of  COPD, when monotherapy and second line therapy with two drugs do not respond adequately.

13.04.2009

67.   

Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + Chlorthalidone 12.5mg

For the tretament of patients with mild to modrate essential hypertension

13.04.2009

68.   

Milnacipran 25/50mg Caps      (Addl. Indication)

For the management of fibromylagia.

15.04.2009

69.   

Lornoxicam SR 16mg Tabs

For the symptomatic treatment of pain and inflammation in patients of osteoarthritis & rheumatoid arthritis

25.04.2009

70.   

Palonosetron Hcl 0.075mg IV Inj (Addl. Strength)

Same as approved

25.04.2009

71.   

Each film coated bilayred tablet contains: Metoprolol 25mg/50mg + Chlorthalidone 6.25 mg /12.5mg

Additional strength

25.04.2009

72.   

Albendazole 400 mg + Ivermectin 6 mg tablet  

For the treatment of intestinal helminthes and suppression of microfilaraemia especially with bancrofti infections

25.04.2009

73.   

Decitabine Lyophilized powder for injection 50mg/20ml vial

For treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes(refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk international Prognostic Scoring System groups.

25.04.2009

74.   

Retapamulin Ointment 1%

For the topical treatment of bacterial skin and skin structure infections:- Primary impetigo, secondarily infected traumatic lesions, secondarily infected dermatoses.

25.04.2009

75.   

Each ml contains Calamine 15% w/v + Zinc oxide 5% w/v + Bentonite 3% w/v+ Glycerin 5%w/v + Sodium citrate 0.05 % w/v lotion

For the tretament of pruritis and prickly heat

08.05.2009

76.   

Each 1000 ml of emulsion contains: Medium chain triglycerides 100 gm + Soya oil 80 gm + Omega-3  acid triglycerides 20 gm + egg lecithin 12 gm + Glycerl 25 gm + Sodium oleate 0.30 gm + Alpha -tocopherol 0.20 gm + Ascorbypalmitate 0.30 gm + Sodium hydroxide max. 0.06 gm + water for injection 784 gm emulsion for infusion

For the supply of fats, including essential omega-6 fatty acids and omega-3 fatty acids, as part of a parenteral nutrition regimen in adults  if oral or enteral nutrition is impossible, inadequte or contraindicated.

14.05.2009

77.   

Sertaconazole Nitrate Powder 2% w/w & Lotion 2% w/v

For the topical treatment of the superficial fungal infections of the skin.

02.05.2009

78.   

Amlodipine Tablets 5mg/10mg  (additional indication)

1. To reduce of fatal coronary heart disease and non-fatal myocardial infarction, and to reduce the risk of stroke.                                   2. To reduce the risk of coronary revascularization procedures and the need for hospitalization due to angina in patients with coronary artery disease.

02.05.2009

79.   

Clindamycin Phosphate Inj. 150mg/ml & Clindamycin HCl Capsules 150mg/300mg (additional indication)

Prophylaxis of infection in neck and head surgery

02.05.2009

80.   

Each 15 gm sachet contains: Lactulose 10 gm + Ispaghula husk 3.50 gm granules

For the treatment of chronic idiopathic constipation in adult patients only

16.05.2009

81.   

Sucralose

for use as sweetner in drug formulations

09.05.2009

82.   

CarvedilolTablets 3.125/6.25/12.5/25mg  (additional indication)

To reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of ≤ 40% (with or without symptomatic heart failure)

09.05.2009

83.   

Dexketoprofen 12.5 mg/25 mg + Paracetamol 500 mg film coated tablets

For the treatment of Acute musculoskeletal pain

18.05.2009

84.   

Pregabalin SR Tablet 150/300mg

For the treatment of peripheral neuropathic pain in adults

16.05.2009

85.   

Guaiphenesin ER Tablet 1200mg

For the treatment of productive cough accompanied by Phlegm

16.05.2009

86.   

Everolimus 5/10mg Tablets (Addl. Indication)

Treatment of advance renal cell carcinoma

16.05.2009

87.   

Nimesulide ER 200mg

( Additional Indication)

Acute pain in Orthopaedic, ENT, Dental and Post Operative condition

16.05.2009

88.   

Palonesetron Injection 0.25mg/5ml (Additional Indication)

For treatment of Post Operative Nausea & vomiting

16.05.2009

89.   

Bendamustine Hydrochloride Lyophilized powder Injection 100mg/ vial

For the treatment of patients with chronic lymphocytic leukemia.

16.05.09

90.   

Caffeine(as  Citrate)       10mg / ml Injection

For the short term treatment of apnoea of prematurity of infants between 28 and < 33 weeks gestational age.

16.05.09

91.   

Perindopril arginine 2.5mg/5mg/10mg  film coated tablet

For the treatment of arterial hypertension, congestive heart failure and coronary artery disease.

16.05.09

92.   

Each gm contains: Halobetasol 0.05% w/w + Mupirocin 2.0 % w/w gel

For the topical treatment of inflammatory dermatitis with secondry bacterial infection

16.05.09

93.   

Mometasone 0.1 % + Fusidic acid 2% cream/ointment

For the treatment of dermatoses where secondry bacterial and/or candidial infection is present

25.04.09

94.   

Thiocolchicoside 8 mg + Etoricoxib 60 mg tablets

Additional strength

25.04.09

95.   

Methadone Hydrochloride 5mg/10mg per ml syrup;  5mg/ 10mg/ 20mg / 40mg  tablet

For the treatment of opiod dependence and in maintainence treatment for opioid dependence.

28.05.09

96.   

Trospium Chloride  film coated tablet 20mg

For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency, and urinary frequency.

28.05.09

97.   

Arformoterol (as Tartrate ) 15mcg / 2ml Inhalation Solution

For the long term, twice daily (morning and evening) maintainence treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

29.05.09

98.   

Zolmitriptan...5.0% w/v   Benzalkonium Chloride NF ... 0.01% w/v        Nasal spray

For the acute treatment of migraine with or without aura in adults.

29.05.09

99.   

 

Dexmedetomidine ( as HCl) 100mcg /ml Injection

For sedation of initially and mechanically ventilated patients during treatment in an intensive care setting.

29.05.09

100.                       

Levetiracetam SR Tablet 500/750/1000mg

same as approved

 

2.05.2009

101.                       

Glatiramer Acetate Injection (20mg/ ml) & Pre-filled syringe (20mg/ml)

For the reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis.

3.06.2009

102.                       

 

Yttrium-90 Microspheres Injection  (Yttrium-90...3GBq (at the time of calibration) per vial)

For the treatment of unresectable metastatic liver tumors from primary colorectal cancer with intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine)

3.06.2009

103.                       

 

Luliconazole Cream 1%

For the treatment of cutaneous mycosis viz. Tinea pedis, Tinea corporis, Tinea cruris.

 

3.06.2009

104.                       

 

Magnesium Valporate Prolonged release tablet 600mg

1) For the treatment of generelized or partial seizures as monothreapy or adjunctive threapy. 2) For prophylaxis of migraine headache in adults. 3) For the treatment of manic episodes associated with bi polar disorders

 

 

4.06.2009

105.                       

Tenofovir Disoproxil Fumerate 300mg

For the treatment of chronic Hepatitis B in adults

19.6.2009

106.                       

 

Bosentan (as monohydrate) Tablets 62.5/125mg

For the treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO Class III or IV symptoms, to improve excercise ability and decrease the rate of clinical worsening.

 

23.6.2009

107.                       

Lornoxicam 12 mg SR (additional strength)

same as approved

26.6.2009

108.                       

 

Azithromycin SR Granules for oral suspension  2000mg

for the treatment for mild to moderate susceptible infection including RTI, uncomplicated skin/ skin structure, non gonococcal urethritis, cervicitis

 

26.6.2009

109.                       

 

Metoprolol 50/50/25 mg  + Atorvastatin 20/10/10 mg  + Ramipril 10/5/2.5 mg capsules

As 2nd line treatment of patients with both essential hypertension and hypercholesterolemia who are not adequately controlled by combination of an anti-hypertensive with lipid lowering agent.

1.07.2009

110.                       

Methyl Phenidate ER Tablet 10/20/30mg

For the treatment of Attention Deficit Hyperactivity Disorder (ADHD)

10.07.2009

111.                       

Dasatinib Tablets 100mg (addl. Strength)

same as approved

10.07.2009

112.                       

 

Voglibose 0.2 mg  + Metformin 500mg Tablets

As 2nd line treatment of type II Diabetes mellitus when diet, exercise and the single agent do not result in adequate glycemic control.

13.7.2009

113.                       

Combipack of artesunate tablet and FDC Tablet of sulphadoxine + pyrimethamine Composition:                                             A. combipack of  1 stip of 3 tablets of artesunate 25 mg and 1 strip of 1 tablet of  sulphadoxine 125mg+ pyrimethamine 6.25 mg                                               

B. combipack of  1 stip of 3 tablets of artesunate 50 mg and 1 strip of 1 tablet of  sulphadoxine 500mg+ pyrimethamine 25 mg                   

C. combipack of  1 stip of 3 tablets of artesunate 100 mg and 1 strip of 2 tablet of  sulphadoxine 500mg+ pyrimethamine 25 mg                                                               D. combipack of  1 stip of 3 tablets of artesunate 200 mg and 1 strip of 3 tablet of  sulphadoxine 500mg+ pyrimethamine 25 mg.

For the treatment of P. falciparum resistant malaria patients

 

 

 

 

 

 

 

 

 

 

 

15.7.2009

114.                       

Milnacipran 100mg (additional Strength)

same as approved

16.7.2009

115.                       

Rifaximin 400mg (additional Indication)

For the treatment of hepatic encephalopathy

18.7.2009

116.                       

Nevirapine tablet 50 mg for oral suspension mg

For the treatment of HIV infection in combination with other anti retro viral agents

18.7.2009

117.                       

Desvenlafaxine (as Succinate) ER Tablets  50mg/100mg

For the treatment of major depressive disorder (MDD)

18.7.2009

118.                       

Posaconazole Oral Suspension 40mg/ml

For the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole.                                            For prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severly immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy. 

18.7.2009

119.                       

Caffeine Citrate 20mg / ml (equivalent to 10mg of Caffeine base) Oral Solution (Addl. Dosage form)

same as approved

18.7.2009

120.                       

Amphotericin B Emulsion 5mg/ml (Addl. Indication)

Febrile Neutropenia in cancer patients

18.7.2009

121.                       

Hydroxy ethyl starch 10% Solution for infusion

For the treatment of imminent or manifest hypovolemia and shock.

18.7.2009

122.                       

Naratriptan (as HCl)  Tablets 1/ 2.5mg

For the acute treatment of migraine with or without aura in adults.

18.7.2009

123.                       

Colistimethate Sodium powder for solution for injection/infusion 500000IU and 2000000IU (additional Strength)

same as approved

20.7.2009

124.  

Simvastatin 20 mg + Ramipril 5mg  + Atenolol 50 mg + HCTZ 12.5 mg + Aspirin 100 mg (EC Pellets) Capsules

For secondary prevention of coronory heart disease/stroke in patients where use of such combination is appropriate

21.7.2009

125.                       

Colistimethate Sodium powder for solution for inhalation 500000IU/1000000IU/2000000IU

Treatment by inhalation of Pseudomonas aeruginosa lung infection in patients with cystic fibrosis

28.7.2009

126.                       

Ramipril MR capsule 10mg

For the treatment of hypertension/ cardiac failure and myocardial infarction

30.7.2009

     127. Abacavir Sulfate Tablet 60mg For the treatment of HIV-1 infection in combination with other antiretroviral agents 1.08.2009
     128. Zoledronic Acid Solution for Infusion Addl. Indication Prevention of clinical fractures after hip fracture in men and women 1.08.2009
      129. Sumatriptan 85 mg + Naproxen 500 mg Tablets Additional Strength  for the treatment of migraine 3.08.2009
     130. Aceclofenac(100mg) + Thiocolchicoside ( 8 mg) tablets For the treatment of acute inflammation conditions associated with spasm in adults only 3.08.2009

  131.

Aceclofenac(100mg) + Thiocolchicoside ( 4 mg) tablets (Additional strength) For the treatment of acute inflammation conditions associated with spasm in adults only 11.08.2009

  132.

Oxcarbazepine 150/300/600mg Tablet (Addl. Indication Treatment of generalized tonic-clonic seizures in adults and children 13.08.2009

133.

Ofloxacin 2mg + Ornidazole 5 mg  per ml Infusion for the treatment of diarrhoea of mixed infection in adult patients 17.08.2009

    134.

Clozapine Tablet200mg (Addl. Strength) Indicated in the management of Schizophrenic patients 19.08.2009

     135.

Oxymetazoline Hydrochloride Nasal Spray50mcg/0.05%w/w Is indicated for the relief of stuffy,running nose associated with colds and influenza, also post nasal drip, sinusitis. 19.08.2009

   136.

Enoxaparin Sodium Injection (Addl.Indication) Treatment of acute ST-segment elevation myocardial infarction including patients to be managed medically or with subsequent percuaneous coronary intervention (PCI) 19.08.2009

    137.

Fluvoxamine Maleate100/150mg ER Tablets For the treatment of obsessive compulsive disorder (OCD)and depression 19.08.2009

    138.

Lidocaine Lozenges 200/300mg (Addl. Indication) For single agent anesthesia in procedure involving the introduction of instrument & tubes into respiratory tract. 19.08.2009

    139.   

Risperidone long acting injection (Addl. Indication) Indicated as monotherapy or as adjunctive therapy in lithium  or valproate for the maintenance treatment of Bipolar-1 disorder. 29.08.2009

140   

Exemestane 25mg Tablet (Addl. Indication) Indicated for adjuvant treatment of Post Menopausal Women with estrogen receptor positive early breast cancer who have received two-three year of tamoxifen and are switched to exemestane for completion of total of five years of adjuvant hormonal therapy. 29.08.2009

141

Artesunate (25/50/100mg) + Amodiaquine (67.5 mg/135/270mg) bilayerd Tablets

For the treatment of uncomplicated malaria due to plasmodium falciparum strain in various age groups

01.09.2009

142

Ezetimibe 10 mg + Fenofibrate 145 mg Film coated tablets

For the treatment of combined hyperlipidemia in patients with normal hepatic and renal function

01.09.2009

143

Buprenorphine Transdermal Patch Each Transdermal Patch having an area of   6.25cm², 12.5cm², and 25cm²contains: Buprenorphine…5mg/10mg/20mg having release rate of 5mcg, 10mcg, 20mcg Buprenorphine per hour respectively(over a period of 7 days).

For the treatment of severe opioid responsive painconditions which are not adequately responding to non-opioid analgesics.For Hospital supply only.

03.09.09

144

 Trospium Chloride ER Capsules 60 mg  For the treatment of overactive bladder with the symptoms of urge urinary incontinence, urgency and urinary frequency.  04.09.2009

145

Metoclopramide (as HCl) 200mg / 400mg per ml Intranasal Solution

For the treatment of nausea and vomiting.

09.09.09

146

Isosorbibe 20 mg  + Hydralazine 37.5 mg tablets

For the treatment of heart failure as an adjunct to standard therapy in patients to improve survival, to prolong time to hospitalization for heart failure and to improve patients reported functional status.

18.09.2009

147

Cefixime 200 mg + Dicloxacillin ER 500 mg Tablets

For the treatment of adult patients with Upper and Lower respiratory tract infections, skin and soft tissue infections

22.09.2009

148

Chlorthalidone Tablet 6.25mg              

For the treatment of mild to moderate hypetension.

03.10.09

149

Cefovecin( as sodium) 80mg/ ml  Lyophilised powder for injection  (Veterinary)             

For the treatment of skin bacterial infections in dogs and cats.

03.10.09

150

Imidacloprid 10% + Moxidectin 1.0% & 2.5%   Topical solution (Veterinary)           Each pippette contains:                             (a) 0.4ml, 1.0ml, 2.5ml, 4ml of 10% Imidacloprid and 1.0% moxidectin             (b) 0.4ml, 0.8ml of 10% Imidacloprid and 2.5% moxidectin  

For the treatment and prevention of flea infestations, prevention of heartworm disease and treatment of infections with gastrointestinal nematodes in dogs and cats.

03.10.09

151

Isoflupredone AcetateSuspension for Injection (2mg per ml) ( For Veterinary)

For the glucocorticoid, anti-inflammatory or supportive therapy to cattle suffering from conditions such as:
(1) Overwhelming infections with severe
toxicity.                                                               (2)   Bovine ketosis.
(3)  Musculoskeletal conditions.
(4)  Shock.
(5) Parturient paresis (supportive stress 
  therapy for milk fever).

03.10.09

152

Saxagliptin (as HCl) 2.5mg/ 5mg Tablets

As an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. (It should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

24.10.09

153

Calcipotriol Gel 0.005%                        (additional dosage form)

For the treatment of moderate plaque psoriasis in adults

3.10.2009

154

Lamotrigine MR Tablets 150mg (Addl. Strength)

same as approved

3.10.2009

155

Metoprolol Tartrate ER Tablet 75mg                                                  (additional strength)

same as approved

3.10.2009

156

Valganciclovir Powder for Oral Solution 50mg/ml

For the treatment of cytomegalovirus (CMV) retinitis in AIDS patients and for prevention of CMV disease in solid organ transplant patients at high risk

9.10.2009

157

Dexketoprofen Trometamol Gel 12.5mg/gm

For the painful and inflammatory conditions associated with joints, tendons, ligaments and muscle

13.10.2009

158

Donepezil Hydrochloride Orodispersible Tablet 5mg/10mg

For the treatment of mild to moderate severe Alzheimer's Dementia

15.10.2009

159

Dexketoprofen Trometamol Injection 50mg/2ml

Symptomatic treatment of acute pain of moderate to severe intensity, when oral administration is not appropriate such as post-operative pain, renal colic and low back pain.

22.10.2009

160

Bromocriptine Mesylate Tablet IP 0.8mg, (additional Indication)

Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

22.10.2009

161

Levosulpride ER Tablet 100/150/200mg

For the treatment of depression and schizophrenia in adults

27.10.2009

162

Ambroxol 30 mg+ Terbutaline 2.5 mg + Guaiphenesin 100mg + Menthol 2.5 mg per 5 ml syrup

Additional strength

27.10.2009

163

Propofol 10 mg+ Lignocaine 2.5 mg per ml injection

Additional strength

27.10.2009

164

Mecobalamin 750 mg + Pyridoxine Hydrochloride1.5 mg + Nicotinamide 45 mg tablets

For the treatment of diabetic neuropathy

27.10.2009

   165

Olmesartan (20/40mg )+  Atorvastatin 5/10/20mg film coated tablets

For the treatment of co-existing essential hypertension and hyperlipidemia in adult patients

27.10.2009

166

Deltamethrin (0.50% m/v) and Piperonyl Butoxide  (2.0% m/v) per ml Pour–On Solution Ready to use pour-on for cattle, sheep and goats.  
1. For use in Cattle to control ticks, stable flies, horn flies, cattle louse flies and nuisance flies e.g. house flies, to kill lice and protection against blackflies.
2. For use in sheep and goats for controlling Karoo paralysis, bont- legged and red-legged ticks
29.10.2009

167

Glucosamine sulphate potassium chloride 500 mg + Ibuprofen IP 200mg film coated Tablets For the treatment of adult patients with osteoarthritis of knee and/or hip joints 03.11.2009

168

Methylcobalamin 1500 mcg + Gabapentin SR 600 mg film coated tablets Additional strength  4.11.2009

169

Propofol 1% for injection (Additional Indication)
1. For conscious sedation for surgical and diagnostic procedures 2. for sedation of ventilated patients receiving intensive care
5.11.2009

170

Rupatadine 10 mg + Montelukast 10 mg Tablets
For the management of seasonal allergic rhinitis (SAR) 10.11.2009

171

Eperisone 50 mg + Paracetamol 500 mg Tablets

For improvement of mytonic conditions caused by neck shoulder arm syndrome , scapulhumeral periarthritis and low back pain in adult patients only 

10.11.2009

172

Lafutidine Tablets ....5mg/10mg.  For the treatment of:
• gastric ulcers, duodenal ulcers and stromal ulcers
• gastric mucosal lesions (erosion, hemorrhage, redness or edema) associated with acute gastritis and acute exacerbation of chronic gastritis.
11.11.2009

173

Ramosetron Hydrochloride Tablets 2.5mcg, 5mcg, 0.1mg & Injecton 0.3mg /2ml  1. Tablets 0.1mg & Injection 0.3-- for the prevention and treatment of gastrointestinal symptoms (nausea and vomiting) associated with emetogenic cancer 
chemotherapy.
2. Tablets 2.5mcg & 5mcg--- for the treatment of diarrhoea predominant irritable bowel syndrome.
11.11.2009

174

Tadalafil tablet 20 mg (Additional Indication) For the treatment of pulmonary arterial hypertension 14.11.2009

175

Flurbiprofen Sodium 0.03% Ophthalmic solution USP for the reduction of post-operative inflammatory condition 14.11.2009

176

Dexmedetomidine HCl Injection (Additional Indication) Sedation of non-intubated patients prior to and/or during surgical and other procedure 14.11.2009

177

Paliperidone ER tablet 12 mg (Additional Strength) Same as approved 14.11.2009

178

1) Triticum Vulgare Topical Cream      Each 100gm of cream contains:
Aqueous extract of Triticum Vulgare (dry residue 200mg / 100ml) ..... 15gm
2-phenoxyethanol Eur. Ph.....1gm 
2) Triticum Vulgare Vaginal Pessary Each 3.5gm of vaginal pessary contains:
Aqueous extract of Triticum Vulgare (dry residue 200mg/ 100ml) .....0.60gm
2-phenoxyethanol Eur. Ph.....0.04gm
1) Triticum Vulgare Cream is indicated for the treatment of ulcers and bed sores.
2) Triticum Vulgare Vaginal Pessary is indicated for the treatment of phlogistic and dystrophic disorders of the female genital tract. 
14.11.2009

179

Febuxostat Tablets 80mg / 120mg For treatment of chronic hyperuricemia in conditions where urate depression has already occured (including a history, or presence of tophus and /or gouty arthritis). 14.11.2009

180

Euphorbia Prostrata Dry Extract :100mg tablet (addl. Indication) For the treatment of 3° and 4° haemorrhoids (Addl. Indication). 14.11.2009

181

Euphorbia Prostrata dry extract ethanolic 80%v/v[(35-70):1] cream 1% w/w For the treatment of 1° and 2° internal haemorrhoids. 14.11.2009

182

Lactobacillus Rhammnosus 1 billion cells + Saccharomyces Boulardi 125 mg + Zinc Enriched yeast 20 mg sachets & capsules  For the treatment of acute diarrhoea in children  4.11.2009

183

Nimesulide 1.0% w/w + Ethanol 31% w/w topical solution For the local application in relieving pain in acute low backache, tendonitis, tenosinovitis and sprains 17.11.2009

184

Diacerein Modified Release Capsule 100mg Symptomatic treatment of osteoarthritis of knee & hip 20.11.2009

185

Amlodipine 5mg/10mg/5mg/10mg/10mg + Valsartan 160mg/160mg/160mg/160mg/320mg + Hydrochlorothizide 12.5mg/12.5mg/25mg/25mg/25mg Tablets  For the treatment of essential hypertension  24.11.2009

186

Maraviroc Tablets 150mg/300mg. For the treatment of patients infected with CCR5- trophic HIV-1. 25.11.2009

187

S (+) Etodolac 150/200/300mg + Paracetamol 500/500/500mg Tablets For the symptomatic treatment of acute pain and inflammation in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis 25.11.2009

188

Tacrolimus Granules for oral suspension 0.2/1 mg per sachet Prophylaxis of transplant rejection in kidney, liver or heart allograft recipient 26.11.2009

189

Rifaximin Dispersible Tablet 200mg For infections diarrhoea in adults 26.11.2009

190

Prednisolone Sodium Phosphate Orally Disintegrating Tablet 10/15/30mg Indicating for condition required Glucocorticoids activity including collagen disease, allergic disease and hypersensitive reaction 26.11.2009

191

Cinitapride Hydrogen Tartrate ER Tablet 3mg For the treatment of gastroesophageal reflux disease (GERD) and functional inconveniences of the gastrointestinal motility 26.11.2009

192

Sevelamer Carbonate (Additional Indication) for control of serum phosphorus in patients with chronic kidney disease on haemodialysis or peritoneal dialysis and patients with CKD not on dialysis with serum phosphate > 5.5 mg/dl 26.11.2009

193

Oxcarbazepine Tablets (Additional Indication)150/300/600 mg Monotherapy in the treatment of partial seizures in children ages 4-16  26.11.2009

194

Ketoprofen plaster 30 mg (7cm X 10 cm) for the relief of musculoskeletal pain & inflammation 11.12.2009

195

Acipimox Capsules 250mg. As adjunctive therapy to diet and weight loss in the treatment of type IIa, IIb and IV lipid disorders.
26.11.2009

196

Amisulpiride SR Tablet 100 mg Same as approved 27.11.2009

197

Mycophenolate Sodium Enteric coated tablet 540 mg (Additional Strength) Same as approved 29.10.2009

198

Loteprednol etabonate 0.5% w/v + Moxifloxacin 0.5% w/v opthalmic Suspension For the treatement of post operative steriod responsive inflammatory ocular infections or risk of bacterial ocular infections exists  1.12.2009

199

Ropinirole ER tablet 2/4/8mg for the treatment of signs & symptoms of idiopathic Parkinson's disease 3.12.2009

200

Diclofenac Diethyl amine transdermal patch 100 mg/37.5 sq cm (Additional Strength) same as approved 4.12.2009

201

Lornoxicam ER Tablet 8 mg (Additional Strength) same as approved 11.12.2009

202

Flurbiprofen plaster 20 mg (7cm X 10cm) for the relief of pain & inflammation due to rheumatoid arthritis , osteoarthritis and allied disorder 11.12.2009

203

Carvedilol Phosphate ER tablet 10/20/40/80mg 1. Mild to severe chronic heart failure. 2. Left ventricular dysfunction following myocardial infarction in clinically stable patients 3. hypertension 11.12.2009

204

Halometasone monohydrate  0.05% w/w + Fusidic acid 2.00% w/w cream

For the treatment of acute and chronic infected eczematous dermatitis

15.12.2009

205

Glimepiride 1/2 mg + Metformin 500 mg + Atorvastatin 10 mg tablets

For the treatment of type II diabetes mellitus associated with dyslipidemia 

17.12.2009

206

Betahistine Di hydrochloride CR capsule 24/32/48mg indicated in the treatment of Menier's syndrome, characterized by unilateral or bilateral tinnitus, vertigo, sensorineural hearing loss 17.12.2009

207

Gefitinib tab 250mg (Additional Indication) Indicated for the first line treatment of patients with locally advanced or metastatic non small cell lung cancer (NSLC) who have activating mutationof the EGFRTK". 18.12.2009

208

Midazolam Hcl Syrup 2mg/ml For selection,anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedure or before induction of anesthesia. 18.12.2009

209

Guaiphenasin Syrup 133mg/5ml For the treatment of productive cough accompanied by phlegm 18.12.2009

210

Balofloxacin Tablet 100mg for the treatment of uncomplicated urinary tract infectins (such as cystitis and urethritis) 22.12.2009

211

Xylometazoline 0.5 mg + Ipratropium 0.6 mg Nasal spray For symptomatic treatment of nasal congestion with running nose (rhinorrhea) 23.12.2009

212

Doxofylline 400 mg + Ambroxol 30 mg Tablets For the treatment of patients with bronchial asthma and COPD, when use of both the drug is appropriate  23.12.2009

213

Ribavirin Capsules 200mg (Addl. Strength) Indicated in combination with peg interferon alpha-2b for the treatment of naïve adult patients with chronic hepatitis C with clinically stable HIV co-infection. 24.12.2009

214

Formoterol 6 mcg + Mometasone furoate 100/200/400mcg Metered dose Inhaler & Dry Powder Inhalation For the treatment of patients with bronchial asthma and COPD, where the use of combination is found appropriate  30.12.2009

215

Chlorohexidine Gluconate Gel 0.2% For the prevention of Plaque and treatment of gengivitis. 30.12.2009
    216 Chlorohexidine Gluconate Mouth wash 0.1% For the prevention of Plaque and treatment of gengivitis. 30.12.2009
    217 Levodropropizine Eur. Ph. 30mg + Chlorpheniramine maleate IP 2mg per 5 ml Syrup For the treatment of non-productive cough  06.07.09