Perrigo Announces FDA Final Approval For Generic Version Of Androgel

Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing AbbVie Inc.'s Androgel® Topical Gel, 1.62% packets (20.25 mg/1.25 g packet and 40.5 mg/2.5 g packet).



Androgel® Topical Gel, 1.62% packets is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Annual market sales for Androgel® Topical Gel, 1.62% packets for the 12 months ending May 2017 were approximately $88 million.



Perrigo Executive Vice President and President Rx Pharmaceuticals John Wesolowski stated, "This final approval is another example of our long-term investment in new products. The Rx team remains committed to providing affordable treatments options for patients in important extended topical categories."



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