U.S. attorneys general urge the FDA to combat counterfeit versions of weight loss drugs developed by Eli Lilly (LLY) and Novo Nordisk (NVO). Read more here.
The FDA has approved the first rapid-acting biosimilar insulin product for glycemic control in people with diabetes. Merilog (insulin-aspart-szjj, Sanofi-Aventis U.S.) was approved as biosimilar to Novolog (Novo Nordisk) for improving blood sugar control for individuals with the condition,
Hims & Hers said on Monday that it may no longer be able to sell compounded versions of the weight-loss drug made by Novo Nordisk because its pathway to do so closed when the U.S. FDA declared Friday that the drug's shortage was over.
Well, at least for Novo Nordisk's Ozempic and Wegovy. Novo Nordisk sales should be going up, and Hims & Hers Health's sales should be going down soon. This morning, the U.S. Food and Drug Administration (FDA) issued a "declaratory order" confirming the "resolution of shortages of semaglutide injection products
Leerink notes that the shortage of Novo Nordisk’s (NVO) semaglutide, marketed as Wegovy and Ozempic, has been resolved according to the FDA.
The Food and Drug Administration said on Friday that the shortage of semaglutide injection products, such as Novo Nordisk's Wegovy, has been resolved. FDA's update led to renewed uncertainty for a growing group of telehealth companies such as Hims & Hers that have built businesses around offering cheaper copies of the branded medications.
Novo Nordisk's (NVO) weight loss therapy Wegovy/Ozempic come out of shortage, but the FDA won't crack down on compounders such as Him & Hers (HIMS). Read more here.
Shortages of Ozempic and Wegovy that have been in place for more than two years have been resolved, as supplies of obesity treatments improve.
The agency first declared a shortage of semaglutide, the main ingredient used to make Ozempic and Wegovy, in 2022.