Updated LIST OF NEW DRUG APPROVED FROM 01-01-2017 to TILL 16-06-2017 BY NEW DRUGS DIVISION, CDSCO
S.No | Name Of Drug | Indication | Date of issue |
1 |
Hydrocortisone Aceponate 0.584 mg/ml Cutaneous Spray Solution (Vet.) | “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 |
8 |
Pasireotide long-acting release 20/40/60mg powder for suspension for injection (Additional Indication) (Pasireotide pamoate) | For the treatment of patients with acromegaly who have had an inadequate response to surgery and/ or for whom surgery is not an option. | 14.02.2017 |
9 | Etonogestrel 68 mg implant | For use by women to prevent pregnancy. | 15.02.2017 |
10 | Bepotastine Besilate 1.5 %w/v Ophthalmic solution | For the treatment of itching associated with allergic conjunctivitis | 22.02.2017 |
11 | Dienogest 2mg Tablets | For the management of Pelvic pain associated with Endometriosis | 09.03.2017 |
12 |
Eprinomectin 0.5% for beef and dairy cattle (vet.) | It is indicated for the treatment and control of gastrointestinal roundworm (including inhibited Ostertagia ostertagi), lungworm, grubs, sucking and biting lice, chlorioptic and sarcoptic-mange mites, and horn flies in beef and dairy cattle of all ages, including lactating dairy cattle. | 14.03.2017 |
13 | Bepotastine Besilate 10 mg Tablets | For the treatment of allergic rhinitis | 27.03.2017 |
14 | Prucalopride 1mg/2mg Tablet (Prucalopride Succinate) | For the treatment of chronic idiopathic constipation in adults in whom laxatives fail to provide adequate relief | 13.04.2017 |
15 | Pomalidomide 1mg/2mg/3mg/4mg Capsules | In combination with dexamethasone, for patient with patient multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. | 01.05.2017 |
16 | Sofosbuvir 400 mg +Velpatasvir 100 mg Tablet & Bulk | For the treatment of adult patients with -chronic Hepatitis C virus, Genotype 1,2,3,4,5 or 6 infection.-Without cirrhosis or with compensated cirrhosis-With decompensated with chronic for use in combination with Ribavirin | 04.05.2017 |