Perrigo Co. 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."
From its beginnings as a packager of generic home remedies in 1887, Allegan, Michigan-based Perrigo Company has grown to become a leading global provider of quality, affordable healthcare products. Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, dietary supplements and active pharmaceutical ingredients (API). The Company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. The Company's primary markets and locations of logistics operations have evolved over the years to include the United States, Israel, Mexico, the United Kingdom, India, China and Australia.
SOURCE: Perrigo  via PR Newswire