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news.Ireland-based Perrigo Company has received an AB therapeutic equivalent rating from the US Food and Drug Administration (FDA) for its previously approved new drug application (NDA) for testosterone gel 1.0%.
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The FDA concluded that the company’s testosterone product is therapeutically equivalent to AbbVie’s AndroGel 1% and can be substituted with the full expectation that it will produce the same clinical effect and safety profile as AndroGel 1% when used under the conditions specified in the labeling.
Other companies that have filed NDAs refering AndroGel 1.0% have failed to achieve the AB rating.
Androgel 1.0% (testosterone gel 1.0%) is used for the treatment of adult males who have low or no testosterone.
Perrigo chairman, president and CEO Joseph Papa said the company is happy to receive an AB rating for its testosterone 1.0% product.
"It occurred as a result of a strong effort by our research and development team, which worked alongside the FDA," Papa said.
"We sincerely commend the FDA team on its actions and appreciate their hard work to bring this matter to conclusion. This highlights our commitment to bringing new affordable products to the market."
The company develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, nutritional products and active pharmaceutical ingredients (API), and receives royalties from Multiple Sclerosis drug Tysabri.