Drug shortages
In its Citizen Petition to the FDA, Novo Nordisk argued that there is no clinical need to allow compounding for liraglutide, the type 2 diabetes injection it sells as Victoza.
After a couple months of uncertainty, the FDA has told compounding pharmacies that they have 60 to 90 days before the agency will enforce rules to stop their production of GLP-1s.
The letters come amid the Outsourcing Facilities Association’s ongoing lawsuit against the FDA over the regulator’s decision to end the shortage for tirzepatide.
Now that they’ve received the go-signal from both U.S. and EU anti-trust regulators, Novo Holdings and Catalent expect to wrap up their deal in the coming days.
Eli Lilly is aggressively ramping up its manufacturing capacity for tirzepatide as compounding pharmacies continue to challenge an FDA decision to formally end the shortage of the obesity and diabetes drug.
In recent months Novo Nordisk has invested several billions of dollars to boost its manufacturing capacity—including its highly contested $16.5 billion merger with CDMO giant Catalent.
Currently, Eli Lilly’s GLP-1 drugs Mounjaro and Zepbound (tirzepatide) are not on the FDA’s shortage list but compounded pharmacies are still making them. That’s unprecedented.
Wednesday’s update to the regulator’s drug shortage database is good news for Novo Nordisk, which has struggled to keep up with demand for the blockbuster GLP-1 drugs.
Novo Nordisk has nominated semaglutide for inclusion in the FDA’s Demonstrable Difficulties for Compounding list, which includes drugs that are too complicated to produce and could pose substantial safety risks to patients if manufactured incorrectly.
Monday’s lawsuits from Eli Lilly are the first to be filed by the pharma since the regulator officially removed tirzepatide from its drug shortage database earlier this month.
PRESS RELEASES