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Perrigo Confirms AB Therapeutic Equivalent Rating From The FDA For Its Testosterone Gel 1.0%
Date:7/24/2014

DUBLIN, July 24, 2014 /PRNewswire/ -- Perrigo Company (NYSE: PRGO; TASE) today announced that it has received an AB therapeutic equivalent rating from the U.S. Food and Drug Administration (FDA) for its previously approved New Drug Application (NDA) for testosterone gel 1.0%. FDA concluded that Perrigo'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 submitted NDAs referencing AndroGel® 1.0% have failed to achieve the AB rating.

Androgel® 1.0% (testosterone gel 1.0%) is indicated to treat adult males who have low or no testosterone. Annual sales were greater than $500 million, as measured by Symphony Health Solutions.

Perrigo's Chairman, President and CEO Joseph C. Papa stated, "We are very pleased to receive an AB rating for our testosterone 1.0% product. It occurred as a result of a strong effort by our research and development team, which worked alongside the FDA. 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."

From its beginnings as a packager of generic home remedies in 1887, Perrigo Company plc, headquartered in Ireland, has grown to become a leading global healthcare supplier. Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, nutritional products and active pharmaceutical ingredients (API), and receives royalties from Multiple Sclerosis drug Tysabri®. The Company is the world's largest manufa
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