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Testosterone Therapy Lawsuits: AndroGel Manufacturer Files Petition Against FDA's Decision on Generic Testosterone Treatment Drug
Date:8/26/2014

Columbus, OH (PRWEB) August 26, 2014

As AbbVie faces testosterone therapy lawsuits, Wright & Schulte LLC has learned that the manufacturer of AndroGel has filed a petition against the U.S. Food & Drug Administration (FDA) for granting bioequivalence status to Perrigo Israel Pharmaceutical’s generic 1% testosterone therapy gel. In giving the generic testosterone gel an AB rating, the FDA determined Perrigo’s product to be therapeutically equivalent to AndroGel 1% testosterone gel and considered the two products interchangeable. AndroGel is a testosterone replacement therapy drug that treats adult males who have low or no testosterone. AbbVie Inc., the maker of AndroGel, who is facing numerous testosterone therapy lawsuits alleging heart attacks and strokes were a result of taking the testosterone medication, has submitted a citizen’s petition to the FDA asking the agency to find that Perrigo’s generic testosterone product was not equivalent to AndroGel. In its denial of AbbVie’s petition, the FDA said that Perrigo’s topical testosterone gel products share common characteristics with AndroGel 1% such as the same active ingredient, dosage form, strength, and the same way of administering the gel. The FDA’s decision comes as testosterone therapy lawsuits are mounting against AbbVie and other testosterone manufacturers in the U.S. District Court, Northern District of Illinois (MDL No. 2545) As of August 15, 2014,

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