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List of Approved Drug for Marketing in India in the
Year 2015

1. Sofosbuvir Tablet 400 mg “In combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults”. 13.01.2015
2. Bedaquiline Tablet. 100 mg “In adults (≥ 18 years), as part of combination therapy of pulmonary tuberculosis due to multi-drug resistant Mycobacterium tuberculosis when an effective treatment regimen cannot otherwise be provided”. 14.01.2015

Lixisenatide pre-filled solution for injection 10µg/20 µg

For the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in patients who are not controlled on existing therapy:

 In combination with the following oral antibiotics:

-Metformin, a sulphonyl urea, or a combination of these agents.

In combination with a basal insulin: alone, in combination with metformin, or in combination with sulphonyl urea.

4 Dapagliflozin Tablet 5mg/10mg

“In adult aged 18 years and older with
 Type-II diabetic mellitus to improve
 glycemic control:  
As mono-therapy when diet and exercise 
alone do not provide adequate glycemic 
control in patients for whom use of 
metformin is considered inappropriate 
due to intolerance. 
                                                                                    As add-on combination therapy in 
combination therapy in combination 
with other glucose- lowering medicinal
 products including insulin, when these,
 together with diet and exercise, do not 
provide adequate glycemic control"

5 Pasireotide solution for injection 0.3mg/0.6mg/0.9mg

“For the treatment of adult patients with Cushing’s disease for whom pituitary 
surgery is not an option or has not been Curative”

6 Emphagliflozin Tablet 10mg/10mg

“As an adjunct to diet and exercise to
 improve glycemic Control in adults with Type 2 diabetes Mellitus.”

7 Gadobutrol solution for injection

"In adult, adolescence and children aged 
2 years and older for:       
1.contrast enhancement in cranial and 
spinal magnetic resonance imaging   
2. Contrast enhancement MRI of other body regions: liver kidneys.  
3.   Contrast enhancement in Magnetic Resonance Angiograpy (CE-MRA)
4.For MRI of the breast to assess the presence and extent of malignant breast 

8 Teneligliptin Tablet 20mg For the treatment of Type 2 Diabetes Mellitus as a Monotherapy adjunct to diet and Exercise 18.05.2015
9  Ceritinib 150 mg Hard Gelatin Capsules 

"For the treatment of patients with
 Anaplastic lymphoma Kinase (ALK)-
positive metastatic non- small cell lung 
cancer (NSCLC) who have progressed on or are intolerant to crizotinib"

10 Vilazodone Hydrochloride 20mg/40mg and Bulk "For the treatment of Major depressive disorders in adults"           19.08.15
11 Gemigliptin 50mg tablets

“ As an adjunct to the diet & exercise to 
improve to improve glycemic control in 
adults with type-2 diabetes mellitus, as an
monotherapy or in  combination with metformin in patients with inadequate glycemic control on metformin alone”

12 Atosiban Acetate Injection 6.75mg/0.9ml and Bulk

 "Indicated to delay imminent pre-term 
birth in pregnant adult women with:
 -regular uterine contractions of at least 30
Seconds duration  at the rate of ≥ 4 per 30
-a cervical dilation  of 1 to 3 cm  (0-3 for
nulliparas) and effacement of ≥50%                                                                                             
- a gestational age  from 24 until 33 
Completed weeks a normal foetal heart rate"

13 Ibrutinib Hard gelatin Capsule 140mg

"For the treatment of adult patients with:-
-mantle cell lymphoma (MCL) who have received at least one prior therapy.                    -Chronic Lymphocytic leukemia (CLL) who have received at least one prior therapy.         
- Chronic lymphocytic leukemia with 17p deletion"                                                                         

14 Ledipasvir (90mg)+ Sofosbuvir (400mg) Tablet " For the treatment of chronic hepatitis C (CHC) Genotype 1 infection in adults"        08.12.2015
15 Ledipasvir Bulk   08.12.2015
16 Daclatasvir Dihydrochloride bulk & Tablet 30mg/60mg "For use with Sofosbuvir for the treatment of patient with chronic hepatitis C virus (HCV) genotype 3 infection” 14.12.2015
17 Enzalutamide 40 mg soft Capsule "For the treatment of adults with metastatic castration resistant prostate cancer whose disease has progessed on or after Docetaxel therapy 18. 12 .2015




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