New Drugs Approved List During the
Period 08.08.2006 To 31.12.2006
|
S. No |
Name of Drug |
Indication |
Date of Approval |
|
1 |
Erdosteine 150mg + Guaiphenesin 50mg + Terbutaline 1.25mg per 5ml
syrup |
Mucolytic |
08.08.06 |
|
2 |
Rosiglitazone (as maleate)2mg + Glibenclamide 5mg + MetFormin 500mg
tablet |
Anti Diabetic |
08.08.06 |
|
3 |
L- Lysine Hcl Ointment (150mg/gm) |
For wounds of various etiology |
08.08.06 |
|
4 |
Levocitirizine 2 Hcl 5mg+ Ambroxol Hcl SR 75mg + Pseudoephedrine Hcl
120mg SR Capsules |
For SAR, PAR & Chronic idiopathic urticatia |
09.08.06 |
|
5 |
Alprazolam SR 0.25mg + Sertraline (As Hcl) 25mg/50mg tablet |
For Panic disorder with or without agoraphobia |
09.08.06 |
|
6 |
Dexibuprofen 200mg/300mg +Paracetamol 500mg tablet |
For RA, OA & ankolysing spondylosis |
10.08.06 |
|
7 |
ISMN SR 60mg + Metoprolol Succinate ER 25/50mg |
For angina & Hypertension |
10.08.06 |
|
8 |
Aspirin 75mg / 150mg + Glycine 37.5mg/75mg tablet |
For prevention of acute coronary syndrome in patients with CAD
prophylaxis against stroke |
10.08.06 |
|
9 |
Combipack of 21 tablet of Quinin sulphate 600mg each & 8 capsule
of Doxycycline (as Hcl) 100mg each) |
For P. Falciparam malaria |
10.08.06 |
|
10 |
Pravastatin 40mg tablet (Additional strength) |
As Approved |
10.08.06 |
|
11 |
Olanzapine powder For oral suspensian (10mg/5ml) |
For schizophrenia in adults |
11.08.06 |
|
12 |
Cefepem (as Hcl) 0.5/1gm + Amikacin (as sulphate) 0.125/0.250gm Inj. |
Antibiotic |
11.08.06 |
|
13 |
Lamivudine 20mg + Nevirapine 35mg + Stavudine 5mg tablet |
Anti HIV |
11.08.06 |
|
14 |
Nadifloxacin (10mg/gm) + Mometasone Furoate (1mg/gm) cream |
For mixed infection of skin |
17.08.06 |
|
15 |
Premetrexed(Disodium) powder For solution For Inj. 500mg/vial |
Anti Cancer |
21.08.06 |
|
16 |
Gliclazide 40mg/80mg + MetFormin Hcl 500mg + Rosiglitazone 2mg tablet |
Ant- diabetic |
22.08.06 |
|
17 |
Tiropramide Hcl (100mg) tablet |
For abdominal spasmodic pain, colics of hepatobilliary track,
abdominal colics |
22.08.06 |
|
18 |
Eperisone Hcl (50mg ) tablet |
For neck-shoulder orm syndrome
scapula hum oral per arthritis and low back pain |
23.08.06 |
|
19 |
Caroverine cap. 20mg & Inj. 40mg/2ml |
For abdominal pain & tinnitus in adult |
23.08.06 |
|
20 |
Paclitaxel nanoparticle Inj. (20mg/ml) |
For metastatic breast cancer |
23.08.06 |
|
21 |
Amoxycillin 250mg + Dicloxacillin 250mg cap. |
Anti biotic |
28.08.06 |
|
22 |
Rifaximine 200mg tab. |
For infections diarrhea in adults |
28.08.06 |
|
23 |
Tigecycline powder For Inj. 50mg/vial |
For skin & skin structure infection & intra abdominal
infection |
28.08.06 |
|
24 |
Stavudine SR 100mg tablet |
Anti HIV |
29.08.06 |
|
25 |
Cefixime (50mg/100mg) + Clavulanic acid 31.125mg/62.5mg per ml dry
syrup & tablet |
Antibiotic |
29.08.06 |
|
26 |
Ciclsonide 80mcg/160mcg + Formotorol 4.5mg inhaler |
Anti asthratic |
29.08.06 |
|
27 |
Ciclsonide 100mcg/ 200mcg/400mcg + Formotorol Fumarate 6mg rotacaps |
Anti asthmatic |
29.08.06 |
|
28 |
Abacavir Sulphate syrup 20mg/ml |
For HIV Infection |
29.08.06 |
|
29 |
S(-) pantoprazole (as sodium) 20mg (E.C.) + Domperidome SR 30mg tablet
|
FOR GERD |
30.08.06 |
|
30 |
Cefadroxil 500mg + Clavulanic acid 125mg tablet |
Antibiotic |
30.08.06 |
|
31 |
Cefadroxil 250mg + Clavulanic acid 62.5mg dispersible tablet |
Antibiotic |
30.08.06 |
|
32 |
Cefadroxil 250mg + Clavulanic acid 62.5mg per 5ml syrup |
Antibiotic |
30.08.06 |
|
33 |
Human Insulin (r-DNA) Powder inhaler |
For type-I & Type-2 Diabetes |
30.08.06 |
|
34 |
Fulvestrant Inj. 250mg/5ml prefilled syringe |
Anti Cancer |
30.08.06 |
|
35 |
S(-) Pantoprazole (as Sodium) Inj. 20mg/vial |
For peptic ulcer, GERD &
Zollinger Ellison Syndrome |
30.08.06 |
|
36 |
Dasatinib tablet 20mg/50mg/70mg tablet |
For chronic hepatitis B infection |
30.08.06 |
|
37 |
Telbivudine 600mg tablet |
For chronic hepatitis B infection |
30.08.06 |
|
38 |
Aprepitant cap (80mg/125mg) |
For chemotherapy induced nausea & vomiting |
30.08.06 |
|
39 |
Telmisartan 40mg + Amlodipine (as Besylate) 5mg tablet |
For essential hypertension |
30.08.06 |
|
40 |
Gemifloxacin (as msylate) 320mg tablet |
Antibiotic |
30.08.06 |
|
41 |
Ceftazidime 500mg /1000mg + Tazobactum (as sodium) 62.5mg/125mg per
vial for injection |
Antibiotic |
30.08.06 |
|
42 |
Cefepime (As Hcl) 500mg/1000mg + Tazobactum (as Sodium) 62.5mg/125mg |
Antibiotic |
30.08.06 |
|
43 |
Paromomycin Inj. 375mg/ml |
For visceral leishmaniasis (Kalaazar) |
30.08.06 |
|
44 |
Cefixime 100mg + Cloxacillin (as Sodium) 500mg + Lactobacillus (45
million spore)tab. |
Antibiotic |
31.08.06 |
|
45 |
Alprazolam Dispersible Tab. 0.125mg/0.25mg/0.50mg |
For anxiety |
20.09.06 |
|
46 |
Epinastine Hcl (0.05%) Opthlamic solution |
For allergic conjunctivitis |
22.09.06 |
|
47 |
Levofloxacin tablet (250mg /500mg) & Infusion 5mg/ml (For
additional indication) |
For prostatitis |
26.09.06 |
|
48 |
Feracrylum 1% mouth gargle 10mg/ml |
As hacmostatic agent in dental surgery |
28.09.06 |
|
49 |
Aceclofenac Inj. (150mg/ml) |
For pain in post operative & post traumatic cases |
28.09.06 |
|
50 |
combipack of one cap. Of aprepitant .125mg & two cap. Of
aprepitant 80mg each (combipack) |
As Approved |
10.10.06 |
|
51 |
Formoterol fumarate 6mcg + Fluficasone propinate 50mcg/125mcg/250mcg
MDI |
For Asthma & COPD |
14.10.06 |
|
52 |
Amlodipine 25mg + Metoprolol 25mg (additional lower strength) |
|
01.11.06 |
|
53 |
Estrogen vaginal tablet 25mcg |
For atropic viginitis |
02.11.06 |
|
54 |
Esomeprazole 40mg (E.C.) + Itopride 150mg SR Capsules |
For GERD |
13.11.06 |
|
55 |
Cefixime 200mg + Cloxacillin 500mg (ER) + Lactobacillus 90 million Spore
tab. (additional strength) |
Antibiotic |
14.11.06 |
|
56 |
Cefixime dispersible tablet 400mg (new dosage Form) |
Antibiotic |
22.11.06 |
|
57 |
Trandalopril 1mg/2mg/4mg/2mg + Verapamil (ER) 240mg/240mg/240mg/180mg |
Anti hypertensive |
23.11.06 |
|
58 |
Ciclesonide 160mcg/320mcg cap. for inhalation |
Anti asthmatic |
28.11.06 |
|
59 |
Rabeprazole 20mg (EC) + Itopride SR 150mg |
For GERD |
28.11.06 |
|
60 |
Metoprolol succinate 25mg /50mg ER + HCTZ 12.5mg |
Anti hypertensive |
30.11.06 |
|
61 |
Atorvastatin 5mg + Fenofibrate 160mg (additional strength) |
As Approved |
01.12.06 |
|
62 |
Aceclofenac Inj. 50mg/ml (additional strength) |
As Approved |
01.12.06 |
|
63 |
Amisulpride 400mg tablet (additional strength) |
As Approved |
01.12.06 |
|
64 |
Misoprostol tablet 25mcg/100mcg/200mcg (additional strength indication |
For cervical ripening, prevention of post partum haemorrhage &
First trimester of aboration with mifepristone |
08.12.06 |
|
65 |
Atazanavir 150mg + Ritonavir 50mg capsules |
Anti HIV |
12.12.06 |
|
66 |
Mebeverine Hcl 135mg + Chlordiazepoxide 5mg tablet |
For IBS |
12.12.06 |
|
67 |
Ampicillin 250mg + Dicloxacillin 250mg tablet |
Antibiotic |
13.12.06 |
|
68 |
Etoricoxib 10mg + Methyl Salicylate 100mg + Mentol 50mg + Linseedoril
30mg per gm. of Gel |
For acute Musculoskeletal pain |
14.12.06 |
|
69 |
Racecadotril dispersible tablet (10mg/30mg) (new dosage Form) |
For diarrhea |
15.12.06 |
|
70 |
Gabapentin ER 450/600/900mg tablet |
For naturopathic pain & partial Seizures |
15.12.06 |
|
71 |
Aceclofenac dispersible tablet 100mg (new dosage form) |
As Approved |
21.12.06 |