A federal judge has upheld the FDA’s decision to remove Eli Lilly’s weight loss and diabetes drugs Zepbound and Mounjaro from the national drug shortage list, Reuters reported May 7.
The ruling, issued in a sealed order by Judge Mark Pittman in the U.S. District Court for the Northern District of Texas, effectively blocks compounding pharmacies from producing lower-cost copies of the drugs.
The order follows months of litigation by the Outsourcing Facilities Association and Farmakeio Custom Compounding that alleged that the FDA relied improperly on Eli Lilly’s own reporting when determining the drugs were no longer in shortage, according to court documents obtained by Becker’s.
On April 29, the plaintiffs filed an unopposed motion to withdraw their appeal to the U.S. Court of Appeals for the Fifth Circuit. The case was formally dismissed May 2, effectively ending the litigation.
A similar lawsuit involving Novo Nordisk’s Ozempic and Wegovy remains pending before the same court.
