US FDA withdraws approval for 2 Ranbaxy generic drugs

The US Food and Drug Administration has rescinded approvals given to Ranbaxy Laboratories for two drugs in 2008, the company informed the Bombay Stock Exchange on Thursday.

The tentative nod given to Ranbaxy to manufacture and sell esomeprazole magnesium delayed-release capsules (20 mg and 40 mg) for heartburn and for anti-viral valganciclovir hydrochloride tablets (450 mg), in February and June of 2008, respectively, have been withdrawn since the regulator felt its decisions to grant approval were in error.

“FDA has said that its original decisions granting tentative approvals were in error because of the compliance status of the facilities referenced in the ANDAs at the time the tentative approvals were granted,” Ranbaxy said.

The company had received approval from FDA to launch the first generic versions of AstraZeneca’s heartburn medicine Nexium and Roche’s antiviral Valcyte. Ranbaxy had, as a result, a six-month period of exclusivity for launching the generic equivalent of Valcyte, which now stands cancelled.

AstraZeneca’s patent on Nexium ended in May this year, while Roche’s patent is to expire in March 2015. Roche had earlier challenged Ranbaxy when it had filed its ANDA for approval, citing alleged patent infringement on valganciclovir. Business Line