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Salix, Progenics Say FDA Advisory Committee To Review RELISTOR SNDA

Salix Pharmaceuticals, Ltd., (SLXP), a developer and marketer of prescription products for the prevention and treatment of gastrointestinal diseases, and Progenics Pharmaceuticals (PGNX), a biopharmaceutical company dedicated to developing innovative medicines, Tuesday announced that the FDA is seeking input from an Advisory Committee on Salix's Supplemental New Drug Application or sNDA for RELISTOR (methylnaltrexone bromide) Subcutaneous Injection, for opioid-induced constipation, or OIC, in patients with chronic pain.

The FDA's action to convene an Advisory Committee was taken in response to the formal appeal by Salix of the complete response action taken by the FDA on July 27, 2012 regarding the RELISTOR sNDA for chronic pain. The FDA has said that it will take action under the appeal after receiving input from the Advisory Committee. The FDA will notify the Company once the Advisory Committee meeting date has been determined, Salix said.

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