Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that on November 20, the Company's development and manufacturing partner received final approval by the U.S. Food and Drug Administration for a generic version of dutasteride capsules, 0.5 mg. The Company immediately initiated commercialization activities through its generic division. This is the 13th generic product launched in 2015 by Impax's generic division.
According to IMS Health (NSP), U.S. brand and generic sales of dutasteride capsules, 0.5 mg were approximately $457 million for the 12 months ending in September 2015.