FDA Pushes Back PDUFA Date for Oral Relistor

The FDA has extended the PDUFA date on Valeant Pharmaceuticals’ oral Relistor NDA for opioid-induced constipation.  The new action date for the methylnaltrexone bromide was moved to July 19.

The FDA wanted more time to review Valeant’s responses to information requests, the firm said.

Valeant gained exclusive rights to the subcutaneous injection from Progenics Pharmaceuticals.