Novo Nordisk Asks U.S. to Stop Compounding Pharmacies from Making Weight-loss Drug Copies

Novo Nordisk on Tuesday asked the U.S. Food and Drug Administration to ban compounding pharmacies from making copycat versions of its popular weight-loss and diabetes drugs, which it said were too complex for those manufacturers to produce safely.

U.S. regulations allow compounders to copy brand-name medicines that are in short supply by combining, mixing or altering drug ingredients to meet demand. Novo’s Wegovy and diabetes drug Ozempic, both known chemically as semaglutide, have been in shortage in the U.S. for much of this year.

In its submission, the Danish drugmaker asked the FDA to consider placing semaglutide on a list of drugs that, even though they are in shortage, are too complex to be copied.

Novo said compounded versions of Wegovy are being sold in incorrect dosage strengths, have been found to contain unknown impurities, and have been linked to nearly 400 serious adverse events since 2018.

The FDA told Reuters it was reviewing Novo’s petition and would respond directly to the drugmaker.

Read more at Reuters >>