FDA approves Perrigo’s NDA for testosterone gel 1%
Published on February 5, 2013 at 11:39 PM
Perrigo Company (Nasdaq: PRGO;TASE) announced that it has received U.S. Food and Drug Administration approval for its New Drug Application (NDA) for testosterone gel 1%. Perrigo's NDA included a bioequivalence study that compared its product to AbbVie's AndroGel® 1%.
AndroGel® 1% (testosterone gel 1%) is indicated to treat adult males who have low or no testosterone. Annual sales were approximately $705 million annually, as measured by Symphony Health.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This filing is another example of our investment in new products and continued focus on bringing extended topicals to market. As always, Perrigo is committed to making quality healthcare more affordable for our customers and consumers."