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Mylan FDA Nebivolol Decision Date Is Postponed by the FDA
Posted on 2005-02-25 06:07:00
Mylan Laboratories Inc. said today that the Food and Drug Administration extended the date for when it must decide whether or not to approve Nebivolol, a high blood pressure treatment submitted by the company's branded drug unit Mylan Bertek Pharmaceuticals.
The FDA pushed back the decision date on the drug to May 31 from Feb. 28 following the submission of a new presentation of already submitted data by the company. Mylan believes the FDA may complete its final review of Nebivolol before the new due date.
The agency requested a new presentation of clinical study data from Mylan on more than 2,000 patients with high blood pressure. Nebivolol is a new generation beta blocker, which also increases nitric oxide levels.
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