List of drugs approved in INDIA – 2013

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Name Of Drug


Date of issue

1 Diclofenac Diethylamine BP 2.32 % w/v Eq to Diclofenac Sodium  2.00 % w/v + Methyl Salicylate IP 10.00% w/v + Menthol 5.00 % w/v +  Absolute Alcohol IP 10.00 % v/v Topical Solution (Additional  Strength) For the Treatment of Acute Lower Back Pain


 2  Telmisartan  20mg + Amlodipine Besylate  Eq. to Amlodipine 2.5mg + Hydrochlorothizide   6.25mg Tablets  (Additional Strength) For the Treatment of Essential  Hypertension


 3 Amlodipine besilate IP Eq. to Amlodipine 10mg + Indapamide SR 1.5 mg  Tablet  (Additional Strength) For the treatment of mild to moderate Hypertension



Nicoumalone Tablets 0.5mg/5mg/6mg

For the prevention and treatment of thromboembolic diseases such as venous thrombosis, atrial fibrillation with embolization, pulmonary embolism and as an adjunct in the treatment of coronary occulsion.


 5 Ruxolitinib Tablet 5mg/15mg/20mg For the treatment of patients with myelofibrosis including primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.


 6 DabigatranEtexilateMesilateeq to DabigatranEtexilate 75mg/110mg/150mg For the prevention of venous thromboembolic events in patients who have undergone orthopaedic surgery 11.2.13
 7 Dexamethasone Intravitreal Implant 0.7mg (in solid polymer drug delivery system) For the treatment of non-infectious uveitis affecting the posterior segment of the eye.  However it should not be used when there is gap in posterior capsule. 20.2.13
 8 Cefixime Tablets 200mg &Cefixime Oral Suspension 100mg/5ml For the treatment of enteric (typhpoid) fever. 22.2.13
 9 DiclofenacColestyramine 145.6mg  Capsule Corresponding to Diclofenac Sodium 75mg (Additional Indication) For the treatment of post-traumatic or post-operative swelling and inflammation 25.2.13
 10 Tadalafil Tablet 2.5mg/5mg 1.For the treatment of erectile dysfunction. 2. For the treatment of erectile dysfunction with benign prostatic hyperplasia. 27.2.13
 11 Azithromycin Tablet 250mg/500mg For the treatment in uncomplicated multidrug resistant enteric fever only 6.3.13
 12 BetahistineDihydrochloride SR Tablets 24mg/32mg/48mg For the symptomatic treatment of peripheral vertigo 14.3.13
 13 Palonosetron Melt in Mouth Tablets 0.5mg For prevention of chemotherapy induced nausea and vomiting 19.3.13
 14 Iobitridol Solution for Injection Each 100mg solution contain 65.81 g Iobitridolcorressponding mass of Iodine 30gm By intracavity route for Arthrography and Hysterosalpingography. 19.3.13
 15 Everolimus 2.5mg/5mg/10mg Tablets 1. For the treatment of tuberous sclerosis complex (TSC) who have renal angiomyolipoma not requiring immediate surgery. 2. For the treatment of postmenopausal women with hormone receptor positive advanced breast cancer in combination with an aromatase inhibitor. 21.3.13
 16  Each sustained release tablet contains:
Thiocolchicoside IP   8/16mg + Lornoxicam 8/16mg (Additional Strength)
For the treatment of patients with acute painful musculoskeletal conditions 08.04.2013
 17 Combination of Lactic Acid Bacteria (VSL#3) Sachet For mild to moderately active ulcerative colitis as an adjunctive therapy subject to condition that it should not be used in patients who are on steroids or immunocompromised. 8.4.13
 18 Tolperisone HCl 450mg + Diclofenac Sodium IP100mg SR tablets  (Additional Strength) For the treament of Patients with acute muscle/musculo skeletal spasm in adult 12.04.2013
 19 Telmisartan IP 80mg + Hydrochlorothiazide IP 25mg uncoated bilayered tablet  (Additional Strength) For the treatment of hypertension as second line therapy 14.05.2013
 20 Carboxy Methyl Cellulose Sodium Lubricant Eye Drops 0.5% w/v (Unit dose pack without preservative) For temporary relief from burning irritation and discomfort due to dryness of the eye or due to exposure to wind or sun.  May also be used as a protectant against further irritation. 27.5.13
 21 Garenoxacin Mesylate tablets 200mg For the treatment of bacterial respiratory tract infection 07.06.13
 22 Trimethoxysilyl Quaternary Ammonium Chloride 0.40% hand protectant and sanitizer Hand Protectant and Sanitizer  for external use.Effective upto 24 hours. 11.06.13
 23 Iron (III) isomaltoside 1000 solution for injection/infusion 100mg per ml For the treatment of iron deficiency anaemia when oral iron preparations are ineffective or cannot be used and when there is a clinical need to deliver iron rapidly. 20.08.13

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