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US FDA panel to review Lux Biosciences' Uveitis candidate Luveniq

Jersey City, New JerseyThursday, May 13, 2010, 08:00 Hrs  [IST]

Lux Biosciences, Inc announced that the Dermatology and Ophthalmology Drugs Advisory Committee of the US Food and Drug Administration (FDA) is scheduled to review its New Drug Application (NDA) for Luveniq (oral voclosporin) for the treatment of non-infectious uveitis involving the intermediate or posterior segments of the eye on June 28, 2010. Lux Biosciences submitted its NDA on February 4, 2010 seeking approval to market Luveniq in the United States; on March 30, 2010, the US FDA accepted the NDA filing for review and granted the NDA priority review. The target PDUFA date for the US FDA to complete its review of the Luveniq NDA is August 3, 2010. The US FDA is not bound by the Advisory Committees' recommendation, but may take its advice into consideration when evaluating the NDA for Luveniq. Lux Biosciences is a privately held biotechnology company focused on the treatment of ophthalmic diseases.

 
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