SILVER SPRING, Md. — The Food and Drug Administration has approved Perrigo’s generic of AbbVie’s Androgel Topical Gel 1.62% packets (testosterone 20.25 mg/1.25 g packet and 40.5 mg/2.5 g packet).
The drug is an androgen indicated for replacement therapy in makes for conditions associated with an absence or deficiency of endogenous testosterone. The drug had annual U.S. sales of $88 million for the 12 months ended May 2017, according to QuintilesIMS data. Perrigo said the approval was for its first-to-file application.
"This final approval is another example of our long-term investment in new products,” Perrigo EVP and president Rx harmaceuticals John Wesolowski said. “The Rx team remains committed to providing affordable treatments options for patients in important extended topical categories."