ALLEGAN — Perrigo Company (Nasdaq: PRGO) announced that it has received U.S. Food and Drug Administration approval for its New Drug Application 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.
Said Perrigo chairman and CEO Joseph C. Papa: “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-based Perrigo has grown to become a leading global provider of over-the-counter and generic prescription pharmaceuticals, infant formulas, nutritional products, dietary supplements and active pharmaceutical ingredients. 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 include the United States, Israel, Mexico, the United Kingdom, India, China and Australia.
More at www.perrigo.com.