List of Drugs Approved during 2011

LIST OF APPROVED DRUG FROM 01-01-2011 to 30-04-2011

Sl.No	Name Of Drug	Indication	Date of issue
1	Alpha lipoic acid USP 100mg + Methylcobalamin 1500mcg + Vitamin B6 IP 3mg + Folic acid IP 1.5mg + Benfotiamine 50mg + Biotin USP 5mg + Chromium Picolinate USP Eq. to Chromuim 200mcg Capsule	For the treatment of diabetic neuropathy	03.01.11
3	Ropinirole ER Tablet 1 mg. (Additional Strength)	Same as approved	04.01.11
4	Erlotinib Hcl Tablet 150 mg (Additional Indication)	Monotherapy for the Maintenance Treatment of Patients with locally advanced metastatic non-small lung cancer whose disease has not progressed after four cycles of Platinum based First Line Chemotherapy.	04.01.2011
5	Moxifloxacin Hcl BP 0.5% w/v + Bromfenac Sodium 0.09% w/v eye drop	For the reduction of post operative inflammatory conditions of the eye	05.01.11
6	Ferrous Ascorbate Eq. to Elemental iron 100mg + Folic acid IP 1.5mg + Cyanocobalamin IP 15mcg + Zinc sulphate monohydrate Eq. to elemental Zinc 22.5mg tablet	For the treatment of iron deficiency anaemia	05.01.11
7	S (+) Etodolac 300mg +Thiocolchicoside 8mg tablet	For the treatment of patients with acute painful musculoskeletal conditions	05.01.11
8	Beclomethasone Dipropionate IP 100mcg + Formoterol Fumarate dihydrate BP Eq. to Formoterol Fumarate 6 mcg Metered Dose Inhaler	For the treatment of bronchial asthma where use of inhaled corticosteriod therapy found appropriate	05.01.11
9	Amlodipine besilate IP Eq. to Amlodipine 5mg + Indapamide USP SR 1.5mg tablet	For the treatment of mild to moderate hypertension	05.01.11
10	Metformin Hcl IP 500mg + Alpha lipoic acid USP 200mg tablet	For the treatment of patients with diabetic polyneuropathy	05.01.11
11	Spironolactone IP 25mg + Furosemide IP 40mg tablet	Additional strength	05.01.11
12	Bicalutamide Tablet 150 mg.(Additional Strength and Indication)	Indicated either alone or as adjuvant to radical Prostatetomy or radiotherapy in Patients with Locally advanced Prostate cancer at High risk for disease Progrssion.	05.01.2011
13	Paracetamol Chewable Tablet 500 mg. ( Additional Dosage Form)	Same as approved	05.01.11
14	Methylcobalamin 500mcg + Folic acid IP 1.5mg + Zinc sulphate IP 25mg + Chromium Polynicotinate 200mcg + Selenium as sodium selenite USP 65mcg + Inositol 100mg + Alpha lipoic acid 50mg + Streptococcus facalis 30million (30 lakh) + Clostridium butyricum 2 million (20 lakh) + Bacillus mesentericus 1 million (10 lakh) + Lactic acid bacillus 50 million (500lakh) capsule	For Vitamins and Minerals deficiency states in adult patients	11.01.11
15	Dextromethorphan Extended Release oral Suspension	For the Relief of Persistent Dry irritating cough in adult patients Only.	17.01.11
16	Hydroquinone USP 2% w/w + Tretinoin USP 0.025% w/w + Allantoin USP 1%w/w Gel	For treatment of hyper pigmentry disorders	31.01.11
17	Paracetamol Fast Release Tablets( Additional Dosage Form)	Same as approved	10.02.11
18	Combikit of tablet & sachet Each bowel preparatory kit contains: One enteric coated tablet Biscodyl IP 5mg & One sachet of powder for reconstitution contains: Polyethylene glycol 3350NF: 210gm + Sodium Bicarbonate IP 2.86gm + Sodium chloride IP 5.6gm + Potassium Chloride IP 0.74gm	For bowel cleansing prior to colonoscopy in adult patients only	11.02.11
19	Ferric Carboxymaltose equivalent to elemental Iron…50mg/ml Injection	For the treatment of iron deficiency in adults when oral iron preprations are ineffective or cannot be used.	11.02.11
20	Pidotimod Tablet 400 mg/800 mg & Oral Solution 400 mg/800 mg per 7ml	For infections of the respiratory system in secondary and primary immunodeficiency with alteration in maturation of T cells in adults only.	11.02.11
21	Ursodeoxycholic Acid Suspension 125mg/5ml and 250 mg /5ml.	For the treatment of patients with chronic cholestatic liver disease.	11.2.11
22	Iloperidone Tablets 1mg/2mg/4mg/6mg/8mg /10mg/12mg	For the acute treatment of adults with schizophrenia.	17.02.11
23	Calf lung surfactant Intratracheal Suspension containing Phospholipids.... 35mg (containing 26 mg phosphatidylcholine of which 16mg is disaturated phosphatidylcholine) Proteins....0.65mg (including 0.26mg of surfactant associated proteins B) per ml	(a). As a prophylaxis therapy for premature infants <29 weeks of gestational age at significant risk for Respiratory Distress Syndrome (RDS). (b). For the treatment of infants <72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotrachteal intubation.	17.02.11
24	Baclofen ER Capsule 10 mg/50 mg. (Additional Strength)	Same as approved	17.02.11
25	Dexketoprofen Trometamol ER tablet 50 mg (Additional Strength)	Same as approved	21.02.11
26	Gatifloxacin Eye drop 5 mg/ml	For the treatrment of bacterial conjunctivitis caused by susceptible strains	21.02.11
27	Paclitaxel Injection 30mg/100 mg/300 mg (additional Indication)	Advanced squmous cell carcinoma of Head and Neck SCCHN: 1. Diagnosed but unrectable locally advanced SCCHN 2. Recurrent SCCHN,if surgery or radiation is not feasible. 3. Palliative treatment of metastatic SCCHN.	2/24/2011
28	Eslicarbazepine Acetate Tablets 200mg/400mg/600mg/800mg	As an adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation.	07.03.11
29	Ketoprofen Plaster ( Size - 7cm x 10 cm)	For the Relief of Musculoskeletal pain and Inflammation.	09.03.11
30	Meropenem IP 1000mg + Sulbactum sodium USP 500mg injection	For the treatment of lower respiratory tract infection caused by gram negative bacteria in adults only	15.03.11
31	Dasatinib 20mg/50mg/70mg (Additional Indication)	Treatment of Newly Diagnosed Adults with Chronic Myeloid Luekemia(CML) in Chronic Phase.	16.03.11
32	Adenosylcobalamin 15mcg + Ferrous Ascorbate Eq. to Elemental iron 100mg + Folic Acid IP 1.5mg + Zinc Sulphate USP Eq. to Elemental Zinc 22.5mg tablet	For the treatment of iron deficiency anaemia in adults only	21.03.11
33	Tioconazole Vaginal Gel 65mg per gm	For the local treatment of vulvovaginal candidiasis in adult patients.	22.03.11
34	Ilaprazole Tablets 5mg/10mg	For the treatment of duodenal ulcer in adults only.	05.04.11
35	Asenapine Maleate Sublingual Tablets 5mg/10mg	For acute treatment of schizophrenia in adults only.	07.04.11
36	Tapentadol Hydrochloride tablets 50mg/75mg/100mg	For relief of moderate to severe acute pain in adults 18 years of age or older.	18.04.11
37	S-Bupivacaine Hydrochloride Injection 2.5mg/5mg/7.5mg per ml	For surgical anaesthesia in adults for epidural (including caesarean section), intrathecal, peripheral nerve block.	28.04.11

Reference: http://cdsco.nic.in/listofdrugapprovedmain.html