Dr Reddy's and Endo International gets US FDA nod to launch generic Valcyte

07 Nov 2014 Evaluate

Dr Reddy’s Laboratories and US firm Endo International Plc have received final approval from US Food and Drug Administration (US FDA) to make cheaper copies of Roche Holding AG's antiviral Valcyte.

The move comes after Ranbaxy Laboratories on Thursday said that FDA had stripped the company of its tentative approval to launch the first copy of the drug due to quality control issues at its manufacturing plants.

Ranbaxy, whose all India-based manufacturing plants have been banned by the FDA from exporting to the United States, also lost its rights to a six-month market exclusivity for Valcyte generic.

Dr. Reddy's is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products - the company offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, bio-similars, differentiated formulations and NCEs.

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