ALLEGAN, Mich. – Perrigo Co. has received Food and Drug Administration approval for its New Drug Application (NDA) for testosterone gel 1%.
The company said Tuesday that its NDA included a bioequivalence study that compared its product with AbbVie's AndroGel 1%.
AndroGel 1% (testosterone gel 1%) is indicated to treat men who have low testosterone or no testosterone. Annual sales are about $705 million, according to Symphony Health data cited by Perrigo.
"This filing is another example of our investment in new products and continued focus on bringing extended topicals to market," Perrigo chairman and chief executive officer Joseph Papa said in a statement.