Testosterone Therapy Lawsuits Continue As AndroGel Manufacturer, AbbVie Inc., Attempted To Block Perrigo’s Generic Testosterone Product From Getting FDA Approval.
Wright & Schulte LLC has learned that the U.S. Food & Drug Administration (FDA) granted 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 in the U.S. District Court, Northern District of Illinois (MDL No. 2545) As of August 15, 2014, there are 177 low testosterone treatment lawsuits pending on behalf of men who allege that they have suffered blood clots, heart attacks, stroke and death as a result of taking testosterone replacement therapy, such as AndroGel, Androderm, and Testim.
[regulations.gov/#!docketDetail;D=FDA-2011-P-0610, July 23, 2014]
[perrigo.investorroom.com/2014-07-24-Perrigo-Confirms-AB-Therapeutic-Equivalent-Rating-From-The-FDA-For-Its-Testosterone-Gel-1-0, July 24, 2014]
Men who use testosterone replacement therapy drugs such as AndroGel, Androderm, Depo-Testosterone and Testim began filing testosterone lawsuits after the FDA’s announcement regarding its review of prescription testosterone medication. The testosterone therapy complaints were filed on behalf of men who contend they have suffered heart attacks, blood clots, strokes and other cardiac events due to taking testosterone treatment medication. Meanwhile, doctors are calling for better research on the issue since some find the current research on testosterone 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]
The firm is actively speaking with men who have sufferance cardiac events from testosterone treatment drugs and urges those who believe they have suffered a heart attack, stroke, or other side-effects from Low-T drugs to contact one of the attorneys at Wright & Schulte LLC by calling 1-800-399-0795 or visit www.yourlegalhelp.com for more information on this and other drug side-effects.
Perrigo filed a lawsuit 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 ordered testosterone drug manufacturers to update their testosterone product labels to reflect the risk of heart attack, stroke, blood clots in the lungs or legs, and increased or irregular heart rate linked with the use of testosterone medication. In August, a class action AndroGel testosterone lawsuit was filed in Canada against AbbVie Products LLC and Abbott Laboratories Ltd., which manufactures and markets AndroGel. The lawsuit contends that Abbott knew, or should have known, the risks associated with using AndroGel and failed to warn the public. The news release issued by the law firms that filed the AndroGel claim said this is the first testosterone replacement therapy class action starting in Canada.
[healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/40587a-eng.php, July 15, 2014]
[marketwatch.com/story/androgel-testosterone-replacement-therapy-class-action-commenced-in-canada-2014-07-24, July 24, 2014]
In January, the FDA announced it was re-evaluating the safety of prescription testosterone replacement therapy drugs after reviewing two observational studies that showed potential cardiovascular problems associated with taking low testosterone medication. A study published in the November 2013 Journal of the American Medical Association found that older men who had an underlying cardiovascular disease and took testosterone replacement therapy had a 30 percent increased risk of a stroke, heart attack or death compared to men who did not take the medication. The second study reviewed by the FDA was published in the PLOS One Journal in January 2014. This study found that men over 65 and younger men with a pre-existing heart disease who were prescribed testosterone drugs were at a greater risk of having a heart attack within the first 90 days after taking the medication for the first time.
[jama.jamanetwork.com/article.aspx?articleid=1764051, November 6, 2013] [fda.gov/Drugs/DrugSafety/ucm383904.htm, January 31, 2014]
[plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0085805, January 29, 2014]
Court documents indicate in that an AndroGel lawsuit was filed in July under MDL 2545 on behalf of a Rhode Island man who alleges he developed heart problems as a result of using low testosterone treatment medication. (Case No. 14C 1748 in MDL 2545) The AndroGel lawsuit, which names AbbVie Inc. as a defendant, stated that the man began taking the prescription medication in 2003 and continued using the drug through 2013. According to the testosterone complaint, the man was diagnosed with coronary artery disease In 2011, allegedly from using AndroGel.
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