Ranbaxy Laboratories said on Thursday the US Food and Drug Administration has withdrawn tentative approvals granted to the company for the generic versions of two drugs, Valcyte and Nexium, because the approval had been issued “in error”.
“FDA has said that its original decision granting tentative approvals were in error because of the compliance status of the facilities referenced in the ANDAs (applications) at the time the tentative approvals were granted,” the company said in a release on the exchanges.
Ranbaxy also said it has lost the 180-day US marketing exclusivity for Valcyte. The company did not comment on whether it retained the Nexium exclusivity.
Valcyte is an anti-viral drug while Nexium is an acid-reflux medicine.
“Ranbaxy is disappointed with this development and is actively evaluating all available options to preserve its rights,” the company said in a statement.
The company management, during a conference call held after its quarterly results announcement, had told analysts that it intends to maintain exclusivity on both drugs and will launch on approval.