FDA approves Impax Laboratories' generic version of Testred Capsules 10 mg

Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has approved its generic version of Testred Capsules 10 mg.

"This represents the second Abbreviated New Drug Application approval from the Hayward, CA facility following resolution of the warning letter in early September 2015," said Fred Wilkinson, President and Chief Executive Office of Impax. "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."

According to IMS Health (NSP), U.S. brand sales of methyltestosterone 10 mg products were approximately $14.5 million for the 12 months ending in July 2015.