Perrigo's Axiron generic approved by FDA
DUBLIN — The U.S. Food and Drug Administration approved Perrigo’s Abbreviated New Drug Application referencing a generic for Eli Lilly’s Axiron Topical Solution, 30 mg/1.5 mL (Testosterone Topical Solution, 30 mg/1.5 mL).
Axiron Topical Solution, 30 mg/1.5 mL is indicated to treat adult males who have low or no testosterone due to certain medical conditions. Annual sales for the 12 months ending January 2017 were approximately $254 million.
Perrigo's CEO John T. Hendrickson stated, "This final approval is another example of making long-term investments in challenging new products. As always, Perrigo is committed to making quality healthcare more affordable for our customers and consumers around the world,” said Perrigo's CEO John T. Hendrickson.