Dr Reddy's, Endo get USFDA approval to launch antiviral Valcyte

The United States Food and Drug Administration (FDA) said it has granted final approval to home-grown pharmaceutical firm Dr Reddy's Laboratories and US-based drugmaker Endo International Plc to make cheaper copies of Roche Holding AG's antiviral Valcyte.

The move comes after Ranbaxy Labs said on Thursday 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 domestic manufacturing plants have been banned by the FDA from exporting to the US, also lost its rights to a six-month market exlusivity for Valcyte generic.

There are no companies with such sales exclusivity for Valcyte generic anymore, FDA spokeswoman Sandy Walsh said in a statement mailed to Reuters.

A spokeswoman for Dr Reddy's did not immediately respond to a request for comment on Friday, while Endo could not be reached outside the US business hours.

(Reuters)