In a major setback for compounding pharmacies, the FDA on Thursday issued a new decision reconfirming that Eli Lilly’s tirzepatide injection shortage is resolved.
For now, compounders will have a grace period of 60 to 90 days before the regulator intends to enforce rules that would put an end to their making off-brand copies of the drug.
“FDA’s determination is based on its analysis of all the information before the agency,” the regulator said in a statement. “The agency does not intend to take action against compounders for violations of the FD&C Act arising from conditions that depend on tirzepatide injection products’ inclusion on FDA’s drug shortage list.”
However, the FDA said it “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.”
In mid-October, the FDA announced that it was rethinking the shortage status of Lilly’s tirzepatide — the active ingredient in Mounjaro for type 2 diabetes and Zepbound for obesity — which the regulator removed from its shortage list earlier in the month, after a lawsuit was filed by the Outsourcing Facilities Association alleging that the agency made a “reckless” and “arbitrary” decision in declaring the end of the shortage.
In Thursday’s update, the FDA said information provided to the regulator by Lilly “demonstrate that the company is currently meeting or exceeding demand for Mounjaro and Zepbound.”
The agency added that it “continues to actively monitor drug availability and is currently working to determine whether the demand or projected demand for each drug in shortage exceeds the available supply.”
When it comes to other GLP-1 products, the FDA on Thursday said Lilly rival Novo Nordisk’s semaglutide — marketed as Ozempic for type 2 diabetes and as Wegovy for obesity — is in shortage.
Both Lilly and Novo Nordisk have invested billions of dollars to ramp up their respective manufacturing capabilities to try and keep up with the unprecedented demand for their type 2 diabetes and obesity medications.
Novo Holdings, the controlling shareholder of Novo Nordisk, announced Wednesday that it completed its $16.5 billion acquisition of CDMO Catalent. In a separate but related transaction, Novo Nordisk on Wednesday announced it completed its acquisition of three Catalent fill-finish sites from Novo Holdings for $11 billion. Located in Italy, Belgium and Indiana, the sites are expected to boost the production of Ozempic and Wegovy.