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07/19/2016 - 00:00

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Valeant and Progenics Announce PDUFA Date Extension for Oral RELISTOR
-Agency requests standard three-month extension to review additional solicited information-

-New PDUFA date set for July 19, 2016-

LAVAL, Quebec and TARRYTOWN, N.Y., April 4, 2016 /CNW/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the Oral RELISTOR (methylnaltrexone bromide) new drug application (NDA) by three months to July 19, 2016. The FDA extended the action date to allow for a full review of Valeant's responses to recent information requests from the FDA.
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Source: press release, 4/04/16. http://ir.progenics.com/releasedetail.cfm?ReleaseID=963260

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June 23, 2015

Valeant and Progenics Announce the Submission of U.S. New Drug Application for Oral RELISTOR®

LAVAL, Quebec and TARRYTOWN, N.Y., June 23, 2015 /CNW/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that Valeant submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for RELISTOR® (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

RELISTOR is a peripherally acting mu-opioid receptor antagonist specifically designed to block the constipating effects of opioid pain medications in the gastrointestinal tract. RELISTOR does not cross the blood-brain barrier, therefore relieving the distressing effects of the constipation without affecting the analgesic effect of the opioid. RELISTOR Subcutaneous Injection has been FDA approved since 2008 to treat OIC in patients with advanced illness who are receiving palliative care, and was approved in 2014 for the treatment of OIC in patients with chronic non-cancer pain.
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Source: press release, 6/23/15. http://ir.progenics.com/releasedetail.cfm?ReleaseID=919083

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