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Last updated on : 08/12/2017
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Approval

LIST OF APPROVED DRUG

LIST OF NEW DRUG APPROVED FROM 01-01-2017 to TILL DATE BY NEW DRUGS DIVISION 

 

S.No

Name of drug

Indication

Date of issue

1

Hydrocortisone Aceponate 0.584mg/ml Cutaneous Spray Solution (Vet.)

For symptomatic treatment of inflammatory and pruritic dermatosis in dogs.

06.01.17

2

Dexlansoprazole Delayed Release Capsule 30/60mg & Bulk

For the treatment of

i)  Healing of all grades of erosive esophagitis (EE).

ii)  Maintaining healing of EE and relief of heartburn.

iii)  Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD).

16.01.17

3

Carfilzomib Sterile Lyophilized Powder for Injection 60mg/vial (50ml vial)

Relapsed or refractory multiple myeloma

  • Carfilzomib for injection is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
  • Carfilzomib for injection is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

17.01.17

4

Dabrafenib 50mg/75mg Capsules

(Dabrafenib Mesylate)

As a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an appropriate test.

In combination with Trametinib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an appropriate test.

18.01.17

5

Trametinib 0.5mg/2mg Tablets

(Trametinib Dimethyl Sulfoxide)

As a monotherapy and in combination with Dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an appropriate test.

18.01.17

6

Alectinib 150mg Capsules (Alectinib Hydrochloride)

For the treatment of patients with anaplastic lymphoma kinase (ALK)-Positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to Crizotinib.

23.01.17

7

Eliglustat 84mg Capsules

(Eliglustat Tartrate or Hemitartrate Salt)

For the long term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an appropriate test.

31.01.17

8 Pasireotide long-acting release 20/40/60mg powder for suspension for injection (Additional Indication) (Pasireotide pamoate) For the treatment of patients with acromegaly who have had an inadequate response to surgery and/ or for whom surgery is not an option.   14.02.2017
9 Etonogestrel 68 mg implant    For use by women to prevent pregnancy.    15.02.2017
10 Bepotastine Besilate 1.5 %w/v Ophthalmic solution       For the treatment of itching associated with allergic conjunctivitis    22.02.2017
11 Dienogest 2mg Tablets    For the management of Pelvic pain associated with Endometriosis    09.03.2017
12 Eprinomectin 0.5% for beef and dairy cattle (vet.)    It is indicated for the treatment and control of gastrointestinal roundworm (including inhibited Ostertagia ostertagi), lungworm, grubs, sucking and biting lice, chlorioptic and sarcoptic-mange mites, and horn flies in beef and dairy cattle of all ages, including lactating dairy cattle.    14.03.2017
13 Bepotastine Besilate 10 mg Tablets    For the treatment of allergic rhinitis    27.03.2017
14 Prucalopride 1mg/2mg Tablet & Bulk  (Prucalopride Succinate) For the treatment of chronic idiopathic constipation in adults in whom laxatives fail to provide adequate relief 13.04.2017
15 Teriflunomide  14 mg tablets      For the treatment of patients with relapsing form of multiple sclerosis 13.04.2017
16 Pomalidomide 1mg/2mg/3mg/4mg Capsules & Bulk In combination with dexamethasone, for patient with patient multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.  01.05.2017
17 Sofosbuvir 400 mg +Velpatasvir 100 mg Tablet                                For the treatment of adult patients with                                                                                                                                               -chronic Hepatitis C virus, Genotype 1,2,3,4,5 or 6 infection.       -Without cirrhosis or with compensated cirrhosis                           -With decompensated with chronic for use in combination with Ribavirin.                                                         04.05.2017
18 Velpatasvir Bulk
 
 
04.05.2017
19
Osimertinib 40 mg/80 mg Film coated Tablets
(Osimertinib Mesylate)
 
For the treatment of patient with metastatic epidermal growth factor receptor (EGFR) T790 M mutation-positive non-small cell lung cancer (NSCLC), as detected by an appropriate test, whose disease has progressed on or after EGFR TKI therapy 29.05.2017
20 Argatroban Hydrate Bulk & Injection 250 mg/2.5 ml 1) For prophylaxis or treatment of thrombosis   in adult patients with Heparin induced thrombocytopenia (HIT).                             2) As an anticoagulant in adults patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary intervention (PCI) 30.05.2017
21
Fluralaner chewable tablets 112.5 mg/250 mg/500mg/1000mg/1400 mg
 
For the treatment of tick and flea infestations on dogs for 12 weeks. This veterinary medicinal product is a systemic insecticide and acaricide with a long duration of action that  provides immediate and persistent tick (adult and juvenile Ixodes ricinus, Ixodes hexagonus, Ixodes scapularis, Ixodes holocyclus, Dermacentor reticulates, Dermacentor variabilis and Rhipicephalus sanguineus) and flea (Ctenocephalides felis and Ctenocephalides canis) killing activity for 12 weeks.
 
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance. the onset of effect is within 8 hours of attachment for fleas (C. felis) and 12 hours of attachment for ticks (I. ricinus)
 
The product effectively controls environmental flea population in area to which treated dogs have access.
 
The product can be used as part of an treatment strategy for the control of Flea Allergy Dermatitis (FAD)
30.5.2017


 
22 Fluticasone Furoate (100 mg mcg) and Vilanterol Trifenatate (25 mcg) powder for inhalation Indicated for the maintenance treatment of the airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/ or emphysema and to reduce exacerbation of COPD in patients with an exacerbation history. 29.06.2017
23 Mirabegron Prolonged Release Tablet 25 mg /50 mg Symptomatic treatment of urgency, increased micturition frequency and / or urgency incontinence as may occur in patients with over active bladder (OAB) Syndrome 12.07.2017
24 Delamanid 50 mg tablet For the use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability   02.08.2017
25 Mirabegron Prolonged Release Tablet 25 mg /50 mg & Bulk Symptomatic treatment of urgency, increased micturition frequency and / or urgency incontinence as may occur in patients with over active bladder (OAB) Syndrome   18.08.2017
26
Efonidipine Hydrochloride Ethanolate Bulk & Tablets 10 mg/20mg/40mg
Indicated for the management of
Hypertension
Renal parenchymal hypertension 
Angina
 28.08.2017
27 Brivaracetam Film Coated Tablets 50mg/75mg/100mg As adjunctive therapy in the treatment of partial -onset seizures in patients 16 years of age and older with epilepsy 07.09.2017
28
Treosulfan Bulk & injection 5g/vial
For the conditioning treatment prior to haematopoetic stem-cell transplantation 26.09.2017
29 Ribociclib 200 mg Film coated Tablets In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of post menopausal women with the hormone receptor (HR)-Positive, human epidermal growth factor receptor 2 (HER2)-Negative advanced or metastatic breast cancer 27.09.2017
30
Dienogest Bulk & 2mg Tablet
For the management of Pelvic pain associated with Endometriosis 28.09.2017
31 Apremilast bulk & film coated tablets 10 mg/20 mg/30 mg
for treatment of patients with moderate to severe plaque psoriasis who are candidate for phototherapy or systemic therapy   
13.10.2017
32 Arbekacin bulk & Injection 200mg/4ml Treatment of following infections caused by Methicillin resistant Staphylococcus aureus (MRSA)", sepsis pneumonia 20.10.2017
33
Benestermycin Intra-mammary suspension (vet.)
 
 
 
For the treatment of subclinical mastitis at drying off, and the prevention of new bacterial infections of the udder during the dry period in dairy cows, caused by bacteria susceptible to penicillin and framycetin    03.11.2017 
34
Midostaurin 25 mg Capsules
In combination with standard induction and consolidation chemotherapy followed by single agent in maintenance of therapy for adult patients with newly diagnosed with acute myeloid leukemia (AML) who are FLT-3 Mutation positive.
For the treatment of adult patients with advanced systemic mastocycosis (Advanced SM)
09.11.2017
35 Tenofovir Alafenamide Fumarate bulk & 25 mg capsules For the treatment of chronic Hepatitis B virus infection in adults with compensated liver disease 10.11.2017
36 Arteolane Maleate and Piperaquine phosphate Dispersible tablets (37.5 mg +187.5 mg
Indicated in children aged 6 months to 12 years for the treatment of :
- Acute uncomplicated Plasmodium falciparum malaria infection
- Acute uncomplicated Plasmodium Vivax malaria infection
 
24.11.2017
37 Macitentan Bulk and Tablets 10 mg Macitentan is an endothelin receptor antagonist (ERA)l indicated for the treatment of Pulmonary arterial hypertension (PAH, WHO group I) to delay disease progression 07.12.2017

 

 

LIST OF NEW DRUG APPROVED FROM 01-01-2016 to TILL DATE BY NEW DRUGS DIVISION 

S.No

Name Of Drug

Indication

Date of issue

1

Nintedanib soft Gelatin Capsule 100/150mg (Nintedanib ethanesulfonate)

For the treatment of Idiopathic Pulmonary Fibrosis

 (IPF).

11.03.16

2

Cisatracurium Besylate Bulk & 2mg/ml injection

As an adjunct to general anaesthesia, to facilitate

tracheal intubation and to provide skeletal muscle relaxation during surgery.

 

14.03.16

3

Fomepizole Bulk & Fomepizole Injection 1.5gm/Ampoule 

As an antidote for Ethylene glycol or Methanol used poisoning or for use in suspected Ethylene glycol or Methanol ingestion, either alone or in combination

 with hemodialysis.

 

14.03.16

4

Tofacitinib Tablets 5 mg(Tofacitinib Citrate)

“For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had

 an inadequate response or intolerance to

Methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs)”.

 

01.04.16

5 Nintedanib Soft Gelatin Capsule 100/150mg (Nintedanib ethanesulfonate) "In combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology after line chemotherapy". 01.04.16

6

Ceftaroline Fosamil Injection 600 mg/Vial

"For the treatment of adult (≥ 18 years of age patients with community-acquired pneumonia".

 

09.05.2016

7 Panobinostat Hard Gelatin Capsules 10mg/15mg/20mg (Panobinostat lactate)  "In combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma, who have received at least 1 prior therapy"      27.05.2016
8
Bepotastine Besilate Bulk &
Bepotastine Besilate 1.5 %w/v
Ophthalmic solution
 
“For the treatment of itching associated with allergic
conjunctivitis”
 
08.06.16
9
Ibutilide Bulk &
Ibutilide Fumarate Injection
0.1mg/ml
"For the rapid conversion of atrial fibrillation or atrial flutterof recent onset to sinus rhythm. Patient with atrial
arrhythmias of longer duration are less likely to respond to Ibutilide Fumarate Injection. The effectiveness of Ibutilidehas not been determined in patients with arrhythmias of more than 90 days in duration”.
 
10.06.16
10 Acotiamide Hydrochloride Bulk & Tablet 100mg "For the treatment of bloating after meals, epigastric bloating and early satiety in functional dyspepsia". 06.07.2016
11 Sacubutril+ Valsartan film coated tablets 50mg/100 mg/200mg  "To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction". 14.07.2016
12 Lurasidone Hydrochloride Bulk & Lurasidone Hydrochloride Tablets 40mg/80mg "For the treatment of Patients with Schizophrenia" 18.07.16
13 Fenticonazole Nitrate Vaginal Capsule 600 mg   "For the treatment of vulvovaginal candidiasis" 10.08.2016
14 Palbociclib Capsules 75mg/100mg/125 mg 
"Palbociclib is a kinase inhibitor indicated in combination with Letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-Positive, human epidermal growth factor receptor 2 (HER2)-Negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease".
11.08.2016
15 Midodrine Hydrochloride 2.5 mg Tablet "For the treatment of symptomatic orthostatic hypotension" 02.09.2016
16 Phospholipids Fraction from Bovine Lung (surfactant) 50 mg/vial

"Preventive use in premature neonates with a high risk of respiratory Distress Syndrome"

12.09.2016
17
Dolutegravir 50 mg Tablet & Bulk (Dolutegravir Sodium)
 
“Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults weighing more than 40 kg” 07.11.2016
18
Alcaftadine Eye Drops 0.25% w/v & Bulk
 
"For the prevention of itching associated with allergic conjunctivitis in patients between the age group 10 to 60 years" 21.11.2016
19 Bepotastine Besilate Bulk   23.11.2016
20 Lenvatinib 4mg/10mg Hard Gelatin Capsules (Lenvatinib Mesylate) "For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer" 02.12.2016
21 Perampanel 2mg/4mg/6mg/8mg/10mg/12mg Tablets "The adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older" 02.12.2016
22 Azilsartan Medoxomil Bulk & 40mg/80mg Tablets "Indicated for the treatment of hypertension in adults patients, either alone or in combination with other antihypertensive agents" 09.12.2016

 

LIST OF APPROVED DRUG FROM 01-01-2015 to 31-01-2015

 

S.No

Name Of Drug

Indication

Date of issue

1

Sofosbuvir Tablet 400 mg

“In combination with other medicinal 
products for the treatment of chronic
Hepatitis C (CHC) in adults”.

13.01.2015

2 Bedaquiline Tablet 100 mg

"In adults (≥ 18 years), as part of  Combination therapy of pulmonary tuberculosis  due to multi-drug resistant  Mycobacterium tuberculosis when an effective treatment regimen cannot  Otherwise be provided”.   

14.01.2015
3

Lixisenatide pre-filled solution for injection 10µg/20 µg

For the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in patients who are not controlled on existing therapy:

 In combination with the following oral antibiotics:

-Metformin, a sulphonyl urea, or a combination of these agents.

In combination with a basal insulin: alone, in combination with metformin, or in combination with sulphonyl urea.

15.01.2015

4

Dapagliflozin Tablet 5mg/10mg

“In adult aged 18 years and older with
 Type-II diabetic mellitus to improve
 glycemic control:  
As mono-therapy when diet and exercise 
alone do not provide adequate glycemic 
control in patients for whom use of 
metformin is considered inappropriate 
due to intolerance. 
                                                                                    As add-on combination therapy in 
combination therapy in combination 
with other glucose- lowering medicinal
 products including insulin, when these,
 together with diet and exercise, do not
 provide adequate glycemic control"

25.02.2015

5 Pasireotide solution for injection 0.3mg/0.6mg/0.9mg
“For the treatment of adult patients with Cushing’s disease for whom pituitary 
surgery is not an option or has not been 
Curative”
18.03.2015
6 Emphagliflozin Tablet 10mg/25mg
“As an adjunct to diet and exercise to
 improve glycemic Control in adults with
 Type 2 diabetes Mellitus.”
07.05.2015
7

Gadobutrol solution for injection

"In adult, adolescence and children aged 
2 years and older for:       
1.contrast enhancement in cranial and 
spinal magnetic resonance imaging   
(MRI).  
2. Contrast enhancement MRI of other body regions: liver kidneys.  
3.   Contrast enhancement in Magnetic Resonance Angiograpy (CE-MRA)
4.For MRI of the breast to assess the
 presence and extent of malignant breast 
07.05.2015
8 Teneligliptin Tablet 20mg For the treatment of Type 2 Diabetes Mellitus as a Monotherapy adjunct to diet and Exercise 18.05.2015
9

 Ceritinib 150 mg Hard Gelatin Capsules 

"For the treatment of patients with
 Anaplastic lymphoma Kinase (ALK)-
positive metastatic non- small cell lung 
cancer (NSCLC) who have progressed on 
or are intolerant to crizotinib"

13.01.2015

10 Vilazodone Hydrochloride 20mg/40mg and Bulk "For the treatment of Major depressive disorders in adults"           19.08.15
11 Gemigliptin 50mg tablets
“ As an adjunct to the diet & exercise to 
improve to improve glycemic control in 
adults with type-2 diabetes mellitus, as an
monotherapy or in  combination with metformin in patients with inadequate 
glycemic control on metformin alone”
        21.08.15
12 Atosiban Acetate Injection 6.75mg/0.9ml and Bulk
 "Indicated to delay imminent pre-term 
birth in pregnant adult women with:
 -regular uterine contractions of at least 30
Seconds duration  at the rate of ≥ 4 per 30
minutes                                                       
-a cervical dilation  of 1 to 3 cm  (0-3 for
nulliparas) and effacement of ≥50%                                                                                             
- a gestational age  from 24 until 33 
Completed weeks a normal foetal heart
rate"

 

        16.09.15
13

Ibrutinib Hard gelatin Capsule 140mg

"For the treatment of adult patients with:-           -mantle cell lymphoma (MCL) who have received at least one prior therapy.                    -Chronic   Lymphocytic leukemia (CLL) who have received at least one prior therapy.         - Chronic lymphocytic leukemia with 17p deletion"                                                                         

07.10.2015

14 Ledipasvir (90mg)+ Sofosbuvir (400mg) Tablet " For the treatment of chronic hepatitis C (CHC) Genotype 1 infection in adults"        08.12.2015
15 Ledipasvir Bulk  

08.12.2015

16

Daclatasvir Dihydrochloride bulk & Tablet 30mg/60mg

"For use with Sofosbuvir for the treatment of patient with chronic hepatitis C virus (HCV) genotype 3 infection”

14.12.2015

17

Enzalutamide 40 mg soft Capsule

"For the treatment of adults with metastatic castration resistant prostate cancer whose disease has progessed on or after Docetaxel therapy

18. 12 .2015

 













Start date: 09/02/2015

End date: 01/12/2066 

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