FDA approves Impax’s Testred generic

HAYWARD, Calif. — Impax Laboratories announced Tuesday that the Food and Drug Administration had approved its generic of Valeant’s Testred (methyltestosterone) capsules. The drug, meant to treat men whose bodies don’t produce enough testosterone naturally, will be available in 10-mg capsules.

“This represents the second Abbreviated New Drug Application approval from the Hayward, Calif., facility following resolution of the warning letter in early September 2015,” Impax president and CEO Fred Wilkinson said. “We expect to be the first generic methyltestosterone capsule to the market and are in the final stages of preparing for commercialization through Impax’s generic division.”

Testred had U.S. sales of about $14.5 million for the 12 months ending July 2015, according to IMS Health data.