List of New Drug Approved from 01 Jan 2016 to 20 May 2016 by CDSCO

Sl. No

Name Of Drug

Indication

Date of issue

1

Nintedanib soft Gelatin Capsule 100/150mg

For the treatment of Idiopathic Pulmonary Fibrosis (IPF).

11.03.16

2

Cisatracurium Besylate Bulk & 2mg/ml injection

As an adjunct to general anaesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery.

14.03.16

3

Fomepizole Bulk &1.5gm/Ampoule

As an antidote for Ethylene glycol or Methanol used poisoning or for use in suspected Ethylene glycol or Methanol ingestion, either alone or in combination  with hemodialysis.

14.03.16

4

Tofacitinib Tablets 5 mg

“For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had  an inadequate response or intolerance to Methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs)”.

01.04.16

5

Ceftaroline Fosamil Injection 600 mg/Vial

"For the treatment of adult (≥ 18 years of age patients with community-acquired pneumonia".

09.05.2016