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

e replacement therapy inconclusive and that leaves them uncertain about how to effectively treat low testosterone problems in men.
[latimes.com/science/sciencenow/la-sci-sn-testosterone-supplement-debate-20140428-story.html, April 28, 2014]

Perrigo filed the petition against the FDA in March in the U.S. District Court for the District of Columbia. (Case No. 1:14-cv-00475) Perrigo said in its complaint that the FDA approved its generic testosterone therapy product in January 2013, but the FDA failed to announce the product’s therapeutic equivalency (TE) to AndroGel by publishing it in the FDA’s “Approved Drug Products With Therapeutic Equivalence Evaluations” publication, also known as the “Orange Book.” According to the complaint, the FDA’s Orange Book is updated every 30 days and contains a listing of all FDA-approved drug products. The complaint further contended that Perrigo repeatedly wrote to the FDA to ask the federal agency to publish the TE rating for the generic testosterone product, but the agency did not do so. In July 2014, the FDA published the TE rating of Perrigo’s generic testosterone product in the July 2014 edition of the Orange Book, after which, Perrigo issued a press release confirming the publication.[perrigo.investorroom.com/2014-07-24-Perrigo-Confirms-AB-Therapeutic-Equivalent-Rating-From-The-FDA-For-Its-Testosterone-Gel-1-0, July 2014]
[fda.gov/downloads/drugs/informationondrugs/ucm086233.pdf, July 2014]

Testosterone replacement products approved by the FDA to treat hypogonadism, which is low testosterone in men due to an underlying medical condition, have come under scrutiny by the FDA and Health Canada. In July, Health Canada issued a warning to patients and healthcare professionals citing the potential life-threatening heart and blood vessel problems associated with testosterone replacement therapy products such as Andriol, Axiom, Delatestryl and Depo-Testosterone. The Canadian government’s health agency ord
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