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news.Mylan Laboratories' branded subsidiary, Mylan Bertek Pharmaceuticals, has revealed that the FDA's decision on whether or not to approve the company's hypertension drug, Nebivolol, will be delayed by up to three months.
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Mylan Bertek was notified by the FDA that the regulator has extended the original ten month Prescription Drug User Fee Act (PDUFA) deadline for the completion of its review of the new drug application (NDA) for Nebivolol. The original action date for the Nebivolol NDA was February 28, 2005.
The extension stems from Mylan Bertek’s recent submission, at the FDA’s request, of an additional presentation of already-submitted data from the Nebivolol NDA.
FDA regulations require that any PDUFA extension be three months, putting the new action date at May 31, 2005. Based upon discussions with the FDA, Mylan believes that it is possible the agency may complete its final review before the new action date.
Nebivolol, a new generation beta blocker that Mylan believes to have a unique profile, is under review for the treatment of hypertension. The NDA is based on data from more than 2,000 patients enrolled in Mylan Bertek clinical trials that evaluated the efficacy and safety of Nebivolol in lowering blood pressure in hypertensive patients.
Mylan licensed the US and Canadian rights to Nebivolol from Janssen Pharmaceutica in 2001. Nebivolol is already registered and successfully marketed in more than 45 other countries outside of North America.