US FDA to Reconsider Decision Barring Compounded Versions of Lilly Weight Loss Drug
The U.S. Food and Drug Administration on Friday agreed to reconsider a decision it made last month to bar drug compounders from selling their own versions of Eli Lilly’s blockbuster weight loss and diabetes drugs.
The agency said in a court filing it would now allow compounding pharmacies and facilities to keep providing the drugs while it reviews whether there is a shortage of their active ingredient. The compounding versions of the drugs are cheaper for patients than the brand-name versions.
The decision was in response to a lawsuit brought on Monday by the Outsourcing Facilities Association, a compounding industry group. After the FDA’s decision on Friday to reconsider, U.S. District Judge Mark Pittman in Fort Worth, Texas put the lawsuit on hold.
The Sept. 30 decision by the FDA endangered the ability of compounders to sell versions of Lilly’s weight loss drug Zepbound and diabetes drug Mounjaro. The FDA decision removed their active ingredient, tirzepatide, from its list of drugs experiencing shortages.
Read more at Reuters >>
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