FDA clarifies stricter stance on GLP-1 compounding: Reuters
The Food and Drug Administration reiterated its increasingly strict stance on compounded versions of GLP-1s, Reuters reported Wednesday.
The FDA said that outside of drug shortages, “routine production” of copycat drugs is not allowed. Producing the compounded versions could now “prompt enforcement action,” Reuters reported.
Hims & Hers, which has historically been one of the largest sellers of copycat GLP-1s, fell more than 4% on Wednesday and slipped further in premarket trading on Thursday.
Hims attracted FDA scrutiny in February when it launched a copy of Novo Nordisk’s new GLP-1 pill. At the time, the FDA said it would take “decisive steps” to restrict GLP-1 compounding in a statement that specifically called out Hims.
After a bitter spat with Novo, which makes Ozempic and Wegovy, Hims entered a pact with the drugmaker in which it agreed not to market compounded GLP-1s.
Hims & Hers, which has historically been one of the largest sellers of copycat GLP-1s, fell more than 4% on Wednesday and slipped further in premarket trading on Thursday.
Hims attracted FDA scrutiny in February when it launched a copy of Novo Nordisk’s new GLP-1 pill. At the time, the FDA said it would take “decisive steps” to restrict GLP-1 compounding in a statement that specifically called out Hims.
After a bitter spat with Novo, which makes Ozempic and Wegovy, Hims entered a pact with the drugmaker in which it agreed not to market compounded GLP-1s.