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- Posted December 19, 2024
FDA Says Shortage of GLP-1 Tirzepatide Is Over
The U.S. Food and Drug Administration re-issued a decision first made by the agency in October that a shortage of the diabetes/weight-loss med tirzepatide is over.
Tirzepatide includes blockbuster injected GLP-1meds Mounjaro (for diabetes) and Zepbound (for weight loss).
The FDA first announced two months ago that any shortage of the meds observed during the summer was over.
However, it was forced to "re-evaluate" that decision after demands by the Outsourcing Facilities Association (OFA), a trade group for compounding pharmacists, which sued the agency claiming that tirzepatide was still in short supply.
As long as the drug shortage was declared, compounding pharmacies were still eligible to produce their own versions of Zepbound/Mounjaro.
However, Thursday's FDA announcement effectively puts an end to that, and compounding pharmacies must now cease producing the lucrative drugs within a set time period.
For many compounding pharmacies that date is 60 days from today (Feb.18) and for "bulk" compounding pharmacies the date is 90 days away (March 19), the FDA said in a statement.
"FDA may still take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe," the agency noted.
Eli Lilly, the maker of Zepbound and Mounjaro, had pushed back against the OFA's assertion that shortages of tirzepatide were still in place, and has also claimed that versions of the drug made by compounded pharmacies are often "untested, unapproved knockoffs," according to NBC News.
As for other popular GLP-1s, the FDA listed these ongoing shortages:
Dulaglutide (Trulicity) injection remains in shortage
Liraglutide (Saxenda) injection remains in shortage
More information
There's more on GLP-1 meds at the Cleveland Clinic.
SOURCES: FDA announcement, Dec. 19, 2024; NBC News
