NEW DRUGS APPROVED BY DRUGS CONTROLLER

LIST OF APPROVED DRUG FROM 01.01.2010 TO 30.4.2010
 

LIST OF APPROVED DRUG FROM 01.01.2010 TO 30.4.2010

S. NO

PRODUCT NAME

INDICATION

DATE OF APPROVAL

1

Ferrous ascorbate 100mg + Folic acid 1.1 mg tablet and Omega-3-fatty acid 200mg capsules combikit

For iron, folic acid & omega-3-fatty acid deficiency 

8-Jan-10

2

Sphaeranthus Indicus Extract Tablets 700mg

For the management of psoriasis.

8-Jan-10

3

Febuxostat 40mg Additional Strength

Same As approved

16-Jan-10

4

Dexamethasone Intravitreal Implant 0.7mg (in solid polymer drug delivery system)

For the treatment of macular edema following branch retinal vein occlusion (CRVO)

16-Jan-10

5

Buclizine Hcl 25mg Tablet (Additional Indication)

For the Symptomatic treatment of various allergic conditions (rhinitis, conjunctivitis and urticaria) and for prevention and treatment of motion sickness

16-Jan-10

6

Pemetrexed Disodium 500mg/100mg Powder for Injection (additional indication)

Indicated as a monotherapy for the maintenance treatment of locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.  First line treatment should be a platinum doublet with gemcitabine, paclitaxel or docetaxel.

16-Jan-10

7

Levobetaxolol HCl Opthalmic Suspension 0.5%

For lowering of intraoccular pressure in patients with chronic open-angle glaucoma or occular hypertension.

16-Jan-10

8

Sarpogrelate Hydrochloride film coated Tablets 100mg

For the improvement of ischemic symptoms including ulcer, associated with chronic arterial occlusion.

16-Jan-10

9

Propanol 1-ol 18gm + Ethanol 100% 45gm/100ml solution

For hygenic and surgical hand disinfection

18-Jan-10

10

Aliskiren 150/160mg + Valsartan  300/320mg tablets

For the treatment of hypertension

19-Jan-10

11

Piroxicam 20mg tab& Paracetamol 500mg tab combikit 

For treatment of fever and pain associated with acute upper respiratory tract inflammation, acute musculoskeletal disorders, pain after operative intervetion and following trauma, chronic condition like rheumatoid arthritis, osteoarthritis etc for short term management of acute painful episodes.

19-Jan-10

12

Soybean oil 60gm + Triglycerides (medium chain) 50gm + olive oil  purified fish oil 30gm + dl-alpha-tocopherol 163-225mg + glycerol (anhydrous) 25gm + Egg lecithin 12gm + sodium hydroxide (to approx pH 8) + sodium pleate 0.3mg emulsion for infusion in 100ml.

Total parenteral nutrition following major abdominal, major thoracic or major urological surgery

19-Jan-10

13

Raltegravir (as Potassium) film coated Tablets 400mg

In combination with other anti retroviral agents for  the treatment of human immunodeficiency virus (HIV-1) infection in treatment experienced patients with evidence of HIV-1 replication despite ongoing retroviral therapy.

27-Jan-10

14

Deflazacort Tablet 18mg (Additional Strength)

Same as approved

30-Jan-10

15

Pregabalin SR Tablet 75mg (Additional Strength)

Same as approved

30-Jan-10

16

Rivaroxaban film coated Tablets 10mg

For the prevention of venous thromboembolism in patients (VTE) in adult patients undergoing hip or knee replacement surgery.

30-Jan-10

17

Cinnarizine 20mg + Dimenhydrinate 40mg tablets 

For the treatment of vertigo

3-Feb-10

18

Lipid Based Amphotericin-B  Gel 0.1%

Indicated in the treatment of cutaneous and mucocutaneous mycotic infections caused by candida (Monilia) species.

5-Feb-10

19

Sodium Hyaluronate Injectable Gel 14mg/ml, 18mg/ml, 25.5mg/ml (Additional Strength)

Same as approved

6-Feb-10

20

Milnacipran Hcl 12.5mg (Addl. Strength)

Same as approved

6-Feb-10

21

Ropinirole 6mg ER Tablets (Addl. Strength)

Same as approved

6-Feb-10

22

Coseal Surgical Sealent 2/4/8ml (Addl. Indication)

(1)  Enforcement of suture and staple lines in lung resection procedures.                                     (2)Patients undergoing cardiac surgery to prevent or reduce the incidence, severity and extend of post surgical adhesion formation.                 (3)Patients undergoing laparotomy or laproscopic abdomino-pelvic surgery as an adjunct to good surgical technique intended to reduce the incidence, severity and extent of post surgical adhesion formation.

6-Feb-10

23

Pregabalin SR 75/150/300mg + Methylcobalamin 1500mcg tablets 

For the treatment of adult patients with peripheral neuropathy

9-Feb-10

24

Ivabradine Hcl Tablets 5/7.5mg (Additional Indication)

 For Symptomatic Treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm, indicated in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is >60bpm.

10-Feb-10

25

Paracetamol Solution for Infusion (10mg/ml) in 50ml (Additional Packsize)

Same as approved

10-Feb-10

26

Ketorolac Tromethamine Ophthalmic Solution 0.45%

Indicated for the treatment of pain and inflammation following cataract surgery.

10-Feb-10

27

Cytarabine Injection 100mg Additional Packsize (20ml)

In combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children.  It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia.  Intrathecal administration of cytarabine is indicated in the prophylaxis and treatment of meningal leukemia.

10-Feb-10

28

Olopatadine Hcl Nasal Spray 0.6% w/w (Additional Indication)

For the relief of the symptoms of seasonal allergic rhinitis in patients 6 years of age and older.

10-Feb-10

29

Sodium chloride 6.80gm + Potassium chloride 0.30 gm + Calcium chloride dihydrate 0.37gm  + Magnesium chloride  hexahydrate 0.20gm + Sodium acetate trihydrate 3.27gm + L-malic acid 0.67gm in 1000ml solution for infusion 

Replacement of extracellular fluid losses in case of isotonic dehydration, especially if acidosis is being imminent or present

11-Feb-10

30

 Chemically Modified Sodium Hyaluronate and           Caboxymethylcellulose Absorbable Adhesion Barrier.

As an adjunct in abdominal or pelvic surgery for reducing the incidence, extent and severity of postoperative adhesions at the site of placement.

11-Feb-10

31

Lornoxicam 4mg/4mg + Thiocolchicoside 4mg/8mg tablets

For the treatment of patients with acute painful musculoskeletal conditions

12-Feb-10

32

Cefixime 100mg/200mg + Cloxacillin 500mg/500mg tablets

For the treatment of adult patients with upper & lower respiratory tract infections, skin and soft tissue infections

12-Feb-10

 

 

33

Celecoxib Mouth Dissolving Tablet 50/100/200 mg For the Treatment of Osteoarthritis and Rheumatoid Arthritis 25-Feb-10

34

Propofol 2% w/v Injection (additionalStrength) Same as Approved 27-Feb-10
35 Spironolactone 25mg + Furosemide 20mg tablets For treatment of resistant oedema associated with secondary hyperaldosteronism; resistant hypertension, chronic cardic failure and hepatic cirrhosis 5/3/2010
36 Olopatadine5mg + Ambroxol30mg tablets  For the management of cough in adult patients only  5/3/2010
37 Methylcobalamin750mcg + Pregabalin75/150mg + Vitamin B61.5mg + Folic acid0.75mg + Benfothiamine7.5mg capsules For the treaetment of painful diabetic neuropathy in adults only  5/3/2010
38 Calcium acetate 435mg + Magnesium carbonate 235mg tablets For the management of hyperphosphatemia in adults patients with renal failure being treated with dialysis (hemodialysis or peritoneal dialysis 5/3/2010
39 Dicyclomine2.5mg + Dried Aluminimum Hydroxide200mg + Light Magnesium Oxide100mg + Simethicone 20mg per 5ml suspension. For the treatment of the symptoms of functional gastrointestinal disorders like irratible bowel syndrome, functional dyspepsia, peptic ulcers., GERD which includes smooth muscle spasm, flatulence, abdominal distension, hyperacdity, gastric distress, bloting etc. 5/3/2010
40 Sertaconazole 2% w/v+ Zinc Pyrithione 1% w/v Shampoo For the treatment in adults patients with dandruff/seborrheic dermatitis of the scalp 5/3/2010
41 Faropenam Sodium Extended Release Tablet 225/300/450 mg For the Treatment of respiratory tract infections, urinary tract infection, skin and skin structure infections and gynaecological infections 8/3/2010
42 Amlodipine5mg + Ramipril10mg/5mg Tablets (additional strength) For the treatment of hypertension only 10/3/2010
43 Doxofylline MR Tablet 650 mg For the treatment of Bronchial Asthma and COPD in Adults 11/3/2010
44 Lidocaine7.5mg + Prilocaine2.5mg per acutation spray For the treatment of adult male patients with premature ejaculation 12/3/2010
45 Pramipexole Di HCl monohydrate ER Tablet 0.375/0.75/1.5/3/4.5 mg For the treatment of the sign and symptoms of idiopathic parkinsons disease 13/3/2010
46 Drosperinone 3mg + Ethinyl Estradiol0.02mg tablets  For the treatment of symptoms of premenstrual dysphoric disorders (PMDD) in women (additional indication) 16/3/2010
47 Miglitol 25 mg + Metformin 500mg tablets Additional Strength 16/3/2010
48 Propranolol 40mg (SR Pellets) + Fluarizine 5mg/10mg capsules  For the prophylaxis of migraine 16/3/2010
49 Citicholine 500mg + Piracetam 400mg Tablets  For the treatment of acute stroke  16/3/2010
50 Diclofenac 50mg + Chlorzoxazone500mg Tablets For the treatment of acute inflammation conditions associated with spasm in adults only 16/3/2010
51 Mecobalamin 750 mcg + Pyridoxine 1.5mg + Nicotinamide 45 mg + Benfotiamine 150mg Tablets For the treatment of diabetic neuropathy in adults 16/3/2010
52 Etoricoxib 1%+ Menthol 5% Spray  For the topical treatment of acute musculoskeletal pain 16/3/2010
53 Pantoprazole 40mg + Cinitapride (ER) 3mg Capsules For the treatment of patients suffering from non-ulcer dyspepsia (NUD) or gasteroesophageal reflux disease (GERD) 17/3/2010
54 Atorvastatin 20mg + Ramipril 2.5mg/5mg Capsules  Additional higher strength 17/3/2010
55 Lamotrigine Orodispersible Tablet 12.5 mg(additional strength) Same as Approved 20/3/2010
56 Trabectedin powder for Conc. solution for infusion (Additional Indication) In combination with pegylated liposomal doxorubicin, it is indicated for the treatment of patients with relapsed platinum- sensitive ovarian cancer 20/3/2010
57 Lornoxicam 8mg/8mg + Thiocolchicoside 4mg/8mg Tablets  Additional higher strength 23/3/2010
58 Diclofenac sodium SR Tablet 150 mg For the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondilytis,gout,painful post perative pain following dental surgery etc. 26/3/2010
59 Magnesium Valproate CR Tablet 200/ 300/400/ 500 mg (additonal strength) Same as Approved  26/3/2010
60 Lidocaine 2.5% w/w+Prilocaine 2.5% w/w Gel Additional higher Strength 26/3/2010
61 Nicotinic Acid and Laropiprant Modified Release Tablets: Nicotinic Acid.........1000 mg
Laropiprant...........20mg 
 
1. For the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDl-cholesterol) and in patients with primary hypercholesterolemia (heterozygous familial and non-familial).
2. In combination with HMG-CoA reductase inhibitors (statins), when cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate. It can be used as monotherapy only in patients in whom HMG-CoA reductase inhibitors are considered inappropriate or not tolerated. Diet or other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy.
 
26/3/2010
62 Pantoprazole Mouth Dissolving Tablet 20/40 mg For the treatment of gastric ulcer, duodenal ulcer & gastroesophageal reflux disease (GERD). 30/3/2010
63 Praziquntel 175mg + Pyrantel 504mg + Febental 525mg Tablets  For the treatment of mixed infections with roundworms and tapeworms in dogs  30/3/2010
64 Difluprednate Opthalmic Emulsion 0.05% w/v For the treatment of inflammation and pain 
associated with ocular surgery. 
 
30/3/2010
65 Tolperisone Hcl SR 450mg Tablets For the relief of painful muscle spasms of the skeletal muscualture. 31/3/2010
66 S(-)Metoprolol 25mg/50mg (ER) + Atorvastatin (IR)10mg tablets  For the treatment of patients with both essential hypertension and hypercholesterolemia 4/1/2010
67 Atorvastatin10mg + Ramipril 5mg + Aspirin (EC pellets) 75mg/150mg + Metoprolol (ER tablets) 25mg Capsules For secondary prophylaxis of ischemic heart disease in patients where use of such combinations in appropriate  5/4/2010
68 Lamotrigine 25mg Modified Release Tablet (Addl. Strength) Same as Approved 5/4/2010
69 Imatinib Mesylate 100/400mg Tablets (Addl. Indication) Adjuvant treatment of adult patients following resection of gastro-intestinal stromal tumours (GIST) 5/4/2010
70 Azithromycin SR Granules for Oral Suspension 1gm (Addl. Strength) Same as Approved 5/4/2010
71 Gemfibrozil Capsule USP & Gemfibrozil Tablet USP 200mg/600mg (Addl. Indication) For the treatment of other dyslipidemias: (a) Fredrickson Types III and V.(b) Associated with diabetes.(C) Associated with xanthomata. 5/4/2010
72 Ibuprofen 400mg + Chlorzoxazone 500mg Tablets For the short term treatment of musculoskeletal pain associated with inflammation and spasm in adults only 7/4/2010
73 Doxophylline (SR) 400mg/800mg + Montelukast 10mg/10mg Tablets  For the treatment of bronchial asthma in adults 7/4/2010
74 Dronedarone( as Hydrochloride) film coated tablet .... 400 mg.  To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age > 70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter > 50mm or left ventricular ejection fraction [LVEF] < 40%), who are in sinus rhythm or who will be cardioverted. 8/4/2010
75 Dosulepin Hcl Tablet 25mg/75mg (Additional Indication) For the treatment of chronic pain. 8/4/2010
76 Prasugrel (as Hydrochloride) film coated tablet ....5 mg / 10mg.  To reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:
Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI). 
Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI.
 
13/4/2010
77 Tofisopam uncoated tablet JP... 50/100mg For the treatment of anxiety and depression. 13/4/2010
78 Zotepine tablet ....25/50/100mg For the treatment of schizophrenia 15/4/2010
79 Armodafinil uncoated tablet ..50/150/250mg To improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), shift work sleep disorder (SWD) or narcolepsy. 23/4/2010
80 Indacaterol ( as Maleate ) Inhalation Powder Hard Capsules .. ...150/300mcg For maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD). 24/4/2010
81 Ranolazine ER Tablets 750mg (Additional Strength) Same as Approved 24/4/2010
82 Tacrolimus Capsules 3mg (Additional Strength) Same as approved 24/4/2010
83 Cefixime 100mg/200mg + Ofloxacin 100mg/200mg Tablets For the treatment of patients with typhoid fever and urinary tract infection in adults  26/4/2010
84 Liquid paraffin 6% + White soft paraffin 15%w/v Cream  For symptomatic relief of dermatological condition associated with dry skin including atopic dermatitis, eczema, pruritus, ichthyosis, xerosis, psoriasis 29/4/2010
85 Levosimendan Injection 2.5mg / ml For the short term treatment of acutely decompensated chronic heart failure (ADHF) in situations where conventional therapy is not sufficient and in cases where ionotropic support is considered appropriate. 30/4/2010

 

View Old Drug Approval

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10. NEW DRUGS APPROVED BY DRUGS CONTROLLER (I) DURING THE PERIOD JANUARY 2010  TO APRIL 2010

9. NEW DRUGS APPROVED BY DRUGS CONTROLLER (I) DURING THE PERIOD JANUARY 2009  TO DECEMBER 2009

8. NEW DRUGS APPROVED BY DRUGS CONTROLLER (I) DURING THE PERIOD JANUARY 2008  TO DECEMBER 2008

7. NEW DRUGS APPROVED BY DRUGS CONTROLLER (I) DURING THE PERIOD JANUARY 2007  TO DECEMBER 2007

6. NEW DRUGS APPROVED BY DRUGS CONTROLLER (I) DURING THE PERIOD SEPTEMBER 2006  TO DECEMBER 2006

5. NEW DRUGS APPROVED BY DRUGS CONTROLLER (I) DURING THE PERIOD JANUARY 1999 TO AUGUST 2006

4. NEW DRUGS APPROVED BY DRUGS CONTROLLER (I) DURING THE PERIOD JANUARY 1999 TO APRIL 2006

3. NEW DRUGS APPROVED BY DRUGS CONTROLLER (I) DURING THE PERIOD JANUARY 1988 TO OCTOBER 2005

2. NEW DRUGS APPROVED BY DRUGS CONTROLLER (I) DURING THE PERIOD JANUARY 1988 TO FEBRUARY 2005

1. NEW DRUGS APPROVED BY DRUGS CONTROLLER (I) DURING THE PERIOD JANUARY 1988 TO AUGUST 2004