Dr Reddy's receives US FDA approval for Valcyte generic

The Hyderabad-based pharma major Dr Reddy's Laboratories Ltd has received the approval of US Food and Drug Administration (US FDA) for making generic version of Roche Holding AG's antiviral Valcyte, according to a Reuters report. In addition to Indian firm, US drug regulator has also granted approval to US firm Endo International Plc for Valcyte.
 
This follows a decision of US FDA to revoke Ranbaxy’s six months exclusivity for generic version of Valcyte due to quality control issues at its manufacturing plants. Except for one manufacturing site in the US, Ranbaxy’s all other facilities have been banned by US FDA from supplying drugs to the US on quality issues.
 
Experts say that US FDA could have for granted Dr Reddy’s and Endo International approvals for Valcyte copycat since there was no low-cost generic of the drug in spite the expiry of its patent.