Novel Drug Approvals for 2014
Drug Name:Novel Drug Approvals for 2014
List Of Brands:
Indication Type Description:
Indication
Indication:
Novel Drug/New Approvals for 2014
(For more salient details please refer the Drug)
No. Drug Name Active Ingred. Apprvl Date FDA Approved use on approved date
M- Manufacturer D- Distributor
1. Mekinist Tablets Trametinib 1/10/ 2014 For use in combination in the Tafinlar capsules Dabrafenib treatment of patients with unresctable or metastatic melanoma with a BRAF V600F or V600F mutation - M- Glaxo Smith Kline LLC
2. Imbruvica Ibrutinib 2/12/2014 For chronic treatment of patients with chronic lymhpcytic leukema (CLL) who received at least one prior therapy.
Ibrutinib previously received accelrated approval on Nov 13 2013 for treatment of patients with mantle lymphoma who have received at ;least one prior therapy - M- Phamacyclics Inc.
3.Azerra Injection Ofatumumab 4/17/2014 Treatment of previously untreated Chlorambucil patients with chronic lymphocytic leukemia(CLL) for whom fludarabine- based therapy is considered M- Glaxo Smith Kline LLC
Novel Drug/New Drug Approvals for 2015 -(Anti-Cancer Drugs)
(For more salient details pleagrefer the Drug)
No. Drug Name Active Ingred. Apprvl Date FDA Approved use on approved date
M- Manufacturer D- Distributor
1.KEYTRUDA Pembroolizumab 9/4/2014 Patients with unresectable or metastatic melanoma and discease progression M- Merck Sharp & Dohme
2. Cyramza Ramucirumab 11/5/2014 Patients with advanced gastric or in combination gastroesophageal junction (GEJ) with paclitexal adenocarcinoma M- Eli Lily and Company
3.Avatin Bevacizumab 11/14/2014 Treatment of patients with platinum in combin with resistent, recurrent epithelial ovarian, paclixtel fallopian tube or primary peritoneal cancer M- Genetech Inc.
4.BLINCYTO Blinatumomab 12/3/2014 Treatment of Philadelphia chromosome- negative relapsed or refractory B-cell purcursor acute lymphoblastic leukemia (R/R ALL) M-Amgen Inc
5.Jafaki Ruxolitinib 12/4/2014 Treatment of patients with plycythemia (PV) who have had an inadequate response to or intolrent of hydroxyurea (HU) M- Incyte Corporation
6.Cyranza Inj Ruxolitinib 12/12/2014 Patients with metastic non-small-lung in combn with cancer (NSCLC) doxetaxel M-Eli Lily and Company
7.Somatuline dep Inj Lanreotide 12/12/2014 Treatment of patients with unresectable, well or moderately differentiated locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression free survival M-Ipsen Pharma
8.Lynparza Olaparib caps 12/19/2014 Monotherapy for treatment of patients with deleterious or suspected deleterious germline BRCA mutated (gBRCAm) as detected by an FDA approved test) advanced ovarian cancer M- AstraZeneca Pharmaceuticals LP)
9.OPDIVO Nivolumab 12/22/2014 Patients with unrectableor metastic melandoma annd disease progression following ipilimumab and if, BRAF V600 mutation positive. a BRAF inhibitor M- Bristol-Myer Squibb Company
