Updated LIST OF NEW DRUG APPROVED FROM 01-01-2017 to TILL 28-02-2017 BY NEW DRUGS DIVISION

S.No

Name Of Drug

Indication

Date of issue

1

Hydrocortisone Aceponate 0.584 mg/ml Cutaneous Spray Solution (Vet.)

F “For symptomatic treatment of inflammatory and pruritic dermatosis in dogs”.

06.01.17

2

Dexlansoprazole Delayed Release Capsule 30/60 mg & Bulk

”For the treatment of:                                                                                                                         I. Healing of all grades of erosive esophagitis (EE)                                                                               II. Maintaining healing of EE and relief of heartburn                                                                             III. Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD)”.

16.01.17

3

Carfilzomib Sterile Lyophilized powder for Injection 60 mg/vial

“Relapsed or refractory multiple Myeloma 

• Carfilzomib for injection is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.

• Carfilzomib for injection is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have receive one or more lines of therapy”.

17.01.17

4

Trametinib 0.5 mg/2mg Tablets

(Trametinib dimethyl sulfoxide)

“As a monotherapy and in combination with Dabrafenib For the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an appropriate test”.

18.01.17

5

Dabrafenib 50 mg/75 mg Capsules

(Dabrafenib Mesylate)

"As a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an appropriate test. In combination with Trametinib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an appropriate test."

18.01.17

6

Alectinib 150mg Capsules (Alectinib Hydrochloride)

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.

23.01.17

7

Eliglustat 84mg Capsules

(Eliglustat Tartrate or Hemitartrate Salt)

For the long term treatment of adult patients with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an appropriate test.

31.01.17