Perrigo confirms FDA approval of testosterone gel 1% Perrigo Company (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 $705M 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."
Galmed and Perrigo sign agreement for aramchol API production Galmed (GLMD) has entered into a Manufacturing Services Agreement with Perrigo (PRGO) subsidiary Perrigo API Ltd. for the large-scale production of the active pharmaceutical ingredient of Galmed's product candidate, aramchol. The API produced pursuant to this agreement is expected to provide sufficient quantities of aramchol for Galmed's potential future Phase III clinical trials of aramchol for the treatment of Non-Alcoholic Steato-Hepatitis, or NASH. The agreement also provides Perrigo with the option to manufacture commercial supplies of the aramchol API in the future.