Updated LIST OF NEW DRUG APPROVED FROM 01-01-2016 to TILL DATE BY NEW DRUGS DIVISION
S.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 |
6 | Panobinostat Hard Gelatin Capsules 10mg/15mg/20mg (Panobinostat lactate) | "In combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma, who have received at least 1 prior therapy" | 27.05.2016 |
7 | Bepotastine Besilate Bulk & Bepotastine Besilate 1.5 %w/v Ophthalmic solution
| “For the treatment of itching associated with allergic conjunctivitis”
| 08.06.16 |
8 | Ibutilide Bulk & Ibutilide Fumarate Injection 0.1mg/ml |
"For the rapid conversion of atrial fibrillation or atrial flutter of recent onset to sinus rhythm. Patient with atrial arrhythmias of longer duration are less likely to respond to Ibutilide Fumarate Injection. The effectiveness of Ibutilidehas not been determined in patients with arrhythmias of more than 90 days in duration”. |
10.06.16 |