Lilly Asks To Join Lawsuit
Date
1/3/2025 10:12:30 AM
(MENAFN- Baystreet)
Eli Lilly (NYSE:LLY) has asked to join in opposing a lawsuit brought by compounding pharmacies against the U.S. Food and Drug Administration over the agency's decision that Lilly's blockbuster weight-loss and diabetes drugs are no longer in short supply.
In a motion filed in Fort Worth, Texas federal court late on Wednesday, Lilly said it could not rely on the FDA to fully defend its interests in the case, which will determine whether compounding pharmacies and facilities can keep selling cheaper versions of the company's weight-loss drug Zepbound and diabetes medicine Mounjaro, which have the same active ingredient, tirzepatide.
The FDA declined to comment. The Outsourcing Facilities Association, which brought the lawsuit along with a Texas compounding pharmacy did not immediately respond to requests for comment.
The compounded drugs at issue, which are essentially copies of the branded prescription medicines but not approved by the FDA, can only be made in significant amounts if there is a shortage.
The FDA decided in October that there was no longer a shortage of the tirzepatide drugs.
In response to the lawsuit, the agency agreed to reconsider its decision but on Dec. 19 affirmed that there is no shortage. At the time, FDA said it would not take any enforcement action for at least 60 days, and the compounding industry is still seeking a court order reversing the agency's decision.
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