Relistor, produced by Tarrytown, N.Y.-based Progenics Pharmaceuticals, was originally approved in 2008 as an injectable.
Protogenics sold the licensing rights of Relistor to Raleigh, N.C.-based Salix Pharmaceuticals in 2011, which was later acquired by Canada-based Valeant for $11.1 billion in 2015.
Valeant agreed to give Progenics a $50 million milestone payment pending the FDA approval.
Valeant and Progenics hope to launch Relistor in the third quarter of 2016.
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