LIST OF APPROVED DRUG FROM 01-01-2011 to 31-12-2011

S.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

2

Ropinirole ER Tablet 1 mg.                  (Additional Strength)

Same as approved

04.01.11

3

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.

04.01.11

4

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

5

Ferrous Ascorbate 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

6

 S (+) Etodolac 300mg +Thiocolchicoside 8mg Tablet

For the treatment of patients with acute painful musculoskeletal conditions

05.01.11

7

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 corticosteroid therapy found appropriate

05.01.11

8

Amlodipine Besilate IP Eq. to Amlodipine 5mg  + Indapamide USP SR 1.5mg Tablet 

For the treatment of mild to moderate hypertension

05.01.11

9

Metformin HCl IP 500mg + Alpha Lipoic Acid USP 200mg Tablet

For the treatment of patients with diabetic polyneuropathy

05.01.11

10

Spironolactone IP 25mg  + Furosemide IP 40mg Tablet 

Additional strength

05.01.11

11

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 Progression.

05.01.11

12

Paracetamol Chewable Tablet 500 mg.                               ( Additional Dosage Form)

Same as approved

05.01.11

13

Methylcobalamin 500mcg  + Folic Acid IP 1.5mg + Zinc Sulphate IP 25mg  + Chromium Polynicotinate 200mcg  + Selenium as Sodium Selenite USP 65 mcg + Inositol 100mg + Alpha Lipoic Acid 50mg + Streptococcus faecalis 30 Millions (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

14

Dextromethorphan  Extended Release Oral  Suspension 30 mg per 5 ml

For the Relief of Persistent Dry irritating cough in adult patients Only.

17.01.11

15

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

16

Paracetamol Fast Release Tablet 500mg             (Additional Dosage Form)

Same as approved

10.02.11

17

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

18

Ferric Carboxymaltose equivalent to elemental Iron…50mg/ml Injection

For the treatment of iron deficiency in adults when oral iron preparations are ineffective or cannot be used.

11.02.11

19

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

20

Ursodeoxycholic Acid Suspension 125mg/5ml and 250 mg /5ml.

For the treatment of patients with chronic cholestatic liver disease.

11.02.11

21

Iloperidone Tablets 1mg/2mg/4mg/6mg/8mg /10mg/12mg

For the acute treatment of adults with schizophrenia.

17.02.11

22

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

23

Baclofen ER Capsule 10 mg/50 mg.             (Additional Strength)

Same as approved

17.02.11

24

Dexketoprofen Trometamol ER Tablet 50 mg (Additional Strength)

Same as approved

21.02.11

25

Gatifloxacin Eye drop 5 mg/ml

For the treatment of bacterial conjunctivitis caused by susceptible strains

21.02.11

26

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.                                                                      

24.02.11

27

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

28

Ketoprofen Plaster           

( Size - 7cm x 10 cm)

For the Relief of Musculoskeletal pain and Inflammation.

09.03.11

29

Meropenem IP 1000mg + Sulbactam sodium USP 500mg injection

For the treatment of lower respiratory tract infection caused by gram negative bacteria in adults only

15.03.11

30

Dasatinib 20mg/50mg/70mg  (Additional Indication)

Treatment of newly Diagnosed Adults with Chronic Myeloid Leukaemia (CML) in Chronic Phase.

16.03.11

31

Adenosylcobalamin 15mcg + Ferrous Ascorbate 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

32

Tioconazole Vaginal Gel 65mg per gm

For the local treatment of vulvo vaginal candidiasis in adult patients.

22.03.11

33

Aspirin (EC Tablets) 75mg/75mg/150mg +Rosuvastatin (Granules) 5mg/10mg/10mg Capsules

For the treatment of dyslipidemia associated with arthersclerotic arterial disease with risk of Myocardial infarction, stroke or peripheral vascular disease.

30.03.11

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

Cefpodoxime IP 100mg/100mg/200mg/200mg +Ofloxacin IP 100mg/200mg/100mg/200mg Tablets

For the Treatment of Lower and upper respiratory tract infection and Typhoid fever in adults only

16.04.11

37

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

38

Cefixime Trihydrate IP Eq. to Anhydrous Cefixime 100mg/200mg + Ofloxacin IP 100mg/200mg Dispersible Tablet

(Additional dosage form )

Same as approved

20.04.11

39

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

40

Dexketoprofen 50mg + Dicyclomine 20mg per 2ml Injection

For the treatment of acute colicky pain in adult patients

28.04.11

41

Gatifloxacin 0.3% + Loteprednol Etabonate 0.5% + Benzalkonium Chloride 0.01% w/v  Opthalmic suspension

For Post-Operative Steroid repulsive inflammatory Ocular conditions when Ocular bacterial infections or a risk of bacterial infection exists

19.05.11

42

Diclofenac Colestyramine 145.6 mg corresponding to 75mg Diclofenac Sodium Capsules.

For the treatment of acute arthritis   (including attacks of gout), chronic arthritis    especially rheumatoid arthritis (chronic polyarthritis), ankylosing spondylitis (Morbus  Bechterew) and other inflammatory,       rheumatoid syndromes of vertebral column.

19.05.11

43

Brinzolamide Ophthalmic Suspension 1%w/v

For the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

26.05.11

44

Besifloxacin Ophthalmic Suspension 0.6% w/v

For the treatment of bacterial conjunctivitis.

31.05.11

45

Diclofenac (as EC Tablets) 25mg + Paracetamol 325 mg Capsule

(Additional Strength)

Same as approved

31.05.11

46

Amlodipine 10mg/10mg+ Telmisartan 40mg/80mg Tablets

 (Additional Strength)

Same as approved

31.05.11

47

1.  PROBIO :

Each sachet (1g) contains:

Total Probiotic.... Not less than  1.25 Billion CFU (Lactobacillus acidophilus,  Lactobacillus rhamnosus, Bifidobacterium longum,  Saccharomyces boulardii) 

2.  PROBIO & PREBIO (F)s 

Each sachet (1g) contains:

Probio (CMP 5)
Total Probiotic
...Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum,  Saccharomyces boulardii)
Fructo Oligo Saccharides      ….   100mg            

3.  PROBIO & PREBIO (D)

Each sachet (1.3g) contains:

Probio (CMP 5)
Total probiotic
... not less than 1.25 billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii)
Fructo Oligo Saccharides...1000mg 

For the treatment of rotavirus diarrhoea.

09.06.11

48

Paracetamol 325mg + Tramadol Hydrochloride 37.5 mg Tablets

Additional indication. (For Symptomatic Treatment of Moderate To Severe Pain.)

21.06.11

49

Silodosin Capsules2mg/4mg/8mg

For the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in adults only.

23.06.11

50

Tiapride Hydrochloride Tablets 25mg/50mg/100mg  

For the treatment of agitation and aggressiveness in adult patients with cognitive impairment.

23.06.11

            51

Eletriptan Hydrobromide Tablets 20mg/40mg

For the treatments of Migraine with or without aura in adults

25.08.11

               52

Glutathione for Injection 600mg

For the treatment of alcoholic liver diseases like alcoholic fatty liver, alcoholic liver fibrosis, alcoholic liver cirrhosis, and hepatitis

14.09.11

            53

Udenafil Tablet 100mg/200mg

For the treatment of erectile dysfunction

15.09.11

                54.

Acrivastine Capsules 8mg

For the symptomatic relief of allergic rhinitis.

26.09.11

            55.

Tacalcitol ointment 4mcg

For the treatment of psoriasis vulgaris in adults only.

26.09.11

 56.

 

Fexofenadine 120mg + Montelukast 10mg Chewable tablet

 

Additional dosage form

 

 

07.07.11

       57.

Each Combipack of 21 tablets contains :

A) FDC of Norgestrel & Ethinyl estradiol tablets IP Each sugar coated white tablet contains:

Norgestrel  0.30mg  & Ethinyl estradiol 0.03mg

B) 7 tablets of Ferrous Fumarate:

Each sugar coated tablet contains : - Ferrous Fumarate  75mg eq. to 24.375mg of ferrous iron

As contraceptive pill for women

27.07.11

58.            

Cefixime (SR) 400mg +Moxifloxacin (SR) 400 mg Tablets

For the treatment of lower respiratory tract infections in adults only

08.08.11

59.            

Alpha Lipoic acid 100mg + Folic acid  1.5mg + Methylcobalamin 1500mcg + Pyridoxine Hydrochloride 3mg + Vitamin D3 1000 IU Tablets

For the treatment of Diabetic neuropathy

10.08.11

60.            

Levosulpride (SR)  75mg + Rabeprazole sodium IP  (EC Pellets) 20mg Capsule

For the treatment of Gastro-oesophageal Reflux Disease (GERD)

19.08.11

61.            

Each Combikit contains

Part A - One film coated tablet of Tenofovir Disoproxil Fumarate 300mg eq. to Tenofovir 245mg + Emtricitabine 200mg.  

Part B - One film coated tablet of Atazanavir sulphate eq. to Atazanavir 300mg + Ritonavir 100mg 

For the treatment of HIV infection in adults.

23.08.11

62.            

Diclofenac sodium  (SR) 100mg  + Eperisone Hydrochloride (SR) 150mg Capsules

For the treatment of patient with acute musculoskeletal spasm associated with low back pain.

24.08.11

63.            

Rosuvastatin Calcium eq. to Rosuvastatin 20mg/20mg + Fenofibrate BP 67.5mg/145mg Tablets

Additional Strength

24.08.11

64.            

Acyclovir 50g + Hydrocortisone 10mg Cream

For the early treatment of recurrent cold sores in adult patients to reduce likelihood of  ulcerative cold sores and to shorten the lesion healing time

30.08.11

65.            

Clindamycin Phosphate eq. to Clindamycin 1% w/w + Hydrous Benzoyl Peroxide eq. to Anhydrous Benzoyl peroxide 2.5% w/w  topical gel

For topical treatment of inflammatory acne vulgaris (Additional lower strength)

30.08.11

66.            

Polyethylene glycol 0.4% w/v + Propylene Glycol 0.3% w/v Eye Drops

For temporary relief of burning and irritation due to dryness of the eye

13.09.11

67.            

Metformin  (ER )1000mg/500mg +Saxagliptin 2.5 mg/5mg

As an Adjunct to diet and exercise to improve glycemic control in adults patients with type 2 diabetes mellitus when treatment with both Saxagliptin and Metformin is appropriate

19.09.11

68.            

Ceftriaxone Sodium eq.  to Ceftriaxone Sodium 1000mg/2000mg + Sulbactam Sodium eq. Sulbactam 500mg/500mg.

Additional Indication - For the treatment of urinary tract infections and lower respiratory tract infections, various bacteria

21.09.11

69.            

Difluprednate 0.05% w/v + Moxifloxacin 0.5% w/v Eye Drops

For steroid responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists

22.09.11

70.            

S(-) Amlodipine 2.5mg/5mg + Clopidogrel 75mg/75mg Tablets

 

For the treatment of high risk hypertensives  who need anti-platelet therapy especially for prophylaxis of artherothrombotic events in patients with a history of recent stroke or established peripheral arterial disease

22.09.11

71.            

Each Combipack contains: -                                   

A) One tablet of Risedronate Sodium -                                         Each film coated tablet contains:

Risedronate Sodium (as Risedronate Sodium Hemi-Pentahydrate) - 35 mg   

B) Six Capsules of FDC of Calcitriol +Calcium carbonate + Zinc

Each soft gelatin capsule contains : -   

Calcitriol IP  - 0.25mcg  

Calcium Carbonate IP    - 500mg (eq. to elemental calcium 200mg)        

 Zinc (as Zinc Sulphate USP)    7.5 mg                                               

For the treatment of Osteoporosis in post menopausal women

 

30.09.11

72

Tafluprost Eye Drops

0.0015% w/v

For the reduction of elevated intraocular pressure in open angle glaucoma and ocular hypertension.

21.10.11

73

Arterolane Maleate

150mg + Piperaquine Phosphate 750mg Tablet

Treatment of acute uncomplicated malaria infection due to Plasmodium falciparum in adults.

19.10.11

74

Diazinon Flea Drops

Spot on Dogs 30.0% w/w

For dogs infected with fleas.

11.11.11

75

Cabazitaxel Injection

60mg / 1.5ml

In combination with prednisone for treatment of patients with hormone-refractory metastatic prostrate cancer previously treated with a docetaxel-containing treatment regimen.

16.11.11

76

Trifluridine Eye Drops 1% w/v

 

For the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex viruses type 1 and 2.

 

08.12.11

 

77

Fosaprepitant (as Dimeglumine) for Injection 150mg.

 

1. Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults.
2. Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.

 

16.12.11

 

78

Abiraterone Acetate Tablets 250mg

 

In combination with prednisone for the treatment of patients with metastatic castration-resistant prostrate cancer who have received prior chemotherapy containing docetaxel.

 

16.12.11

 

79

Dabigatran Etexilate( as Mesilate) hard gelatin Capsules 75mg/110mg/150mg

 

For prevention of stroke, systemic embolism and reduction of vascular mortality in adult patients with atrial fibrillation.

 

12.12.11

 

80

Crizotinib  hard gelatin Capsules 200mg/250mg

 

For the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) – positive as detected by an FDA-approved test.

 

16.12.11

 

 

 

 

 

 

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