The Outsourcing Facilities Association filed a lawsuit against the U.S. Food and Drug Administration (FDA) regarding its recent decision to remove tirzepatide (better known as Mounjaro and Zepbound) from the drugs shortage list.
The Association filed its suit alleging that the removal of tirzepatide would mean that FDA would not allow compounders to compound this drug anymore.
The Association alleges in its complaint that the removal of these product from the drug shortage list violated the Administrative Procedures Act by not going through the correct procedures for an administrative agency such as FDA.
The following drugs still remain on drug shortage according to FDA:
- Dulaglutide injection: In shortage.
- Semaglutide injection: In shortage. Manufacturer has reported all but one of the presentations are available.
- Liraglutide injection: In shortage. Manufacturer has reported 2 presentations are available, and three have limited availability.
A drug compounding industry group on Monday sued the U.S. Food and Drug Administration over its decision to take Eli Lilly's (LLY.N), opens new tab blockbuster weight loss and diabetes drugs off its list of medicines in short supply last week.
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