Dr. Reddy's approved for generic Valcyte

NEW YORK — Dr. Reddy's Labs received approval from the Food and Drug Administration for a generic version of of Roche Holding's antiviral medication Valcyte, according to a Reuters report. 

 

Valcyte had sales in the United States of $368 million in 2013, representing a 12% increase from the prior year, according to the report. Ranbaxy Labs said that the FDA had dismissed the company's approval to launch the first generic verion of the drug because of quality control issues at its manufacturing facilities, the report said. 

 

Ranbaxy also lost rights to marketing exclusivity for the generic version. According to an FDA spokeswoman, no companies have sales exclusivity for generic Valcyte anymore.