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,
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.
The FDA has now resolved the shortages of Novo Nordisk and Eli Lilly’s blockbuster weight-loss drugs, which could spell the end to the booming market for cheaper versions made by pharmacies.
The FDA has declared an end to the shortage of Novo Nordisk’s blockbuster drug semaglutide, threatening the ability for compounding pharmacies to make copies of Ozempic and Wegovy.
Semaglutide — the key ingredient in Ozempic and Wegovy — had been in shortage since 2022. Now that supply has stabilized, state-licensed compounding pharmacies and physicians must stop selling compounded semaglutide by April 22, while outsourcing facilities have until May 22 to cease production and distribution.
The FDA has announced that the shortage of Wegovy and Ozempic, medications used for weight loss and diabetes management, is over.