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Tuesday, 10/01/2013 2:34:23 PM

Tuesday, October 01, 2013 2:34:23 PM

Post# of 97239
PGNX Salix and Progenics Announce FDA Advisory Committee Scheduled to Review Relistor sNDA for Opioid-Induced Constipation in Patients with Chronic Pain
Salix Pharmaceuticals, Ltd. (SLXP) and Progenics Pharmaceuticals (PGNX) today announced that the FDA will convene an Advisory Committee on March 10-11, 2014 at which time Salix's Supplemental New Drug Application (sNDA) for RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection, for opioid-induced constipation, or OIC, in patients with chronic pain will be considered. The date and agenda for the Advisory Committee will not be definitive until publication in the Federal Register.
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 stated that it will take action under the appeal within 30 days after receiving input from the Advisory Committee.
http://finance.yahoo.com/news/salix-progenics-announce-fda-advisory-183000775.html

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