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

S. NO APPROVED DRUG INDICATION APPROVAL DATE
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
3.

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.

15.01.2015
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"

 
25.02.2015
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”

18.03.2015
6 Emphagliflozin Tablet 10mg/10mg

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

 
07.05.2015
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   
(MRI).  
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 

 
07.05.2015
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"

13.01.2015
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”

        21.08.15
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
minutes                                                       
-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"

        16.09.15
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"                                                                         

07.10.2015
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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