The Food and Drug Administration has declared an end to the shortage of Novo Nordisk’s blockbuster drug semaglutide, threatening the ability for compounding pharmacies to make copies.
Novo’s semaglutide, sold under the brand names Ozempic for diabetes and Wegovy for obesity, had been on the FDA’s drug shortage list for over two years. During that time, patients flocked to compounders, which were allowed to make copies of semaglutide since it was on the shortage list. Patients were also drawn to compounded semaglutide since it was cheaper than the brand-name version, which carries a list price of about $1,000 a month.
The FDA has given compounders time to wind down semaglutide copies, saying it won’t take enforcement actions against a category of state-licensed compounders until April 22 and won’t take actions against another category known as outsourcing facilities until May 22.
This article is exclusive to STAT+ subscribers
Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+.
Already have an account? Log in