Usfda Approval

Zydus Lifesciences has received a significant approval from the US FDA for Enzalutamide capsules, which are used in treatment of metastatic castration-resistant prostate cancer.

Natco Pharma gets USFDA approval for Tipiracil Hydrochloride and Trifluridine Tablets

The US Food and Drug Administration (USFDA) granted final approval to the abbreviated new drug application (ANDA) for Tipiracil Hydrochloride and Trifluridine Tablets, the generic version of Lonsurf sold in the US by Taiho Oncology Inc, Natco said in a regulatory filing.

Lupin gets USFDA nod for generic antiviral medication

The company has received approval from the US Food and Drug Administration (USFDA) for Tenofovir Alafenamide tablets (25 mg), the Mumbai-based drug firm said in a statement.

Zydus gets USFDA nod for two generic drugs

The company has also received final approval from the US Food and Drug Administration (USFDA) to market Pregabalin capsules in multiple strengths, the Ahmedabad-based drug maker said in a statement.

Strides gets USFDA nod for generic drug with 180-day exclusivity

Singapore-based Strides Pharma Global Pte, a step-down wholly-owned subsidiary of the company, has received approval for its product from the US Food and Drug Administration (USFDA).

Mkt size of latest generic drug is $300mn: Panacea Biotec

Rajesh Jain, joint managing director, Panacea Biotec expects the USFDA approval for the collaborated drug by next year to early-2016.

Glenmark gets USFDA approval for sclerosis treatment drug

Glenmark Generics Inc, the US-based subsidiary of Glenmark Generics Ltd (GGL) has received final approval from the US Food and Drug Administration (USFDA) for Riluzole tablets in 50 mg strength, Glenmark Pharma said in a statement.

USFDA approval of plant a shot in the arm for Ranbaxy

In what could be the biggest boost for Ranbaxy in more than three years, sources suggest that the US FDA has given an approval for Ranbaxy's finished dosage plant in Mohali, reports Archana Shukla of CNBC-TV18.

Pfizer's Lipitor to go off-patent: Will Ranbaxy cash-in?

In eight days, Pfizer's patent for anti-cholesterol blockbuster drug Lipitor will expire. CNBC-TV18's Archana Shukla reports on what the markets and various companies involved expect from the world's largest selling drug.

USFDA nod a strong trigger for Zenotech despite legal issue

In a latest mishap, Zenotech failed to pay salaries to its employees for the first time in its eight year history due to non-payment of dues by majority shareholder - Ranbaxy. Promoter Jayram Chigurupati feels that the company is being neglected by Ranbaxy, reports CNBC-TV18's Appaji Reddem.