22.09.2015 13:27:23
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Impax Receives FDA Approval For Generic Version Of Testred Capsules
(RTTNews) - Impax Laboratories, Inc.(IPXL) announced that the U.S. Food and Drug Administration (FDA) has approved its generic version of Testred Capsules 10 mg.
This is the second Abbreviated New Drug Application approval from the Hayward, California-based facility following resolution of the warning letter in early September 2015.
The company said it expects to deliver the first generic methyltestosterone capsule to the market and are in the final stages of preparing for commercialization through Impax's generic division.
The U.S. brand sales of methyltestosterone 10 mg products were about $14.5 million for the 12 months ending in July 2015, according to IMS Health.
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