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FDA Approvals - Response Submitted to FDA Approvable Letter for Hypertension Compound Nebivolol


Response Submitted to FDA Approvable Letter for Hypertension Compound Nebivolol (PR Newswire via Yahoo! Finance)
Forest Laboratories, Inc. announced today that its licensing partner Mylan Laboratories submitted a response to the approvable letter issued by the United States Food and Drug Administration for the compound nebivolol, a selective beta 1- blocker with vasodilating properties currently under U.S. regulatory review for the treatment of hypertension.

Indian pharma firms corner chunk of US drug approvals (Business Standard India)
As the Indian pharmaceutical companies aggressively pursue research and development to capture the market for drugs going off-patent, a dozen companies led by Aurobindo Pharma, Wockhardt, Ranbaxy, Dr Reddy s Lab and Sun Pharma have bagged almost one-fourth of generic drug approvals in the US in the four-and-a-half month from December 2006.
 

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