The FDA on Thursday said it continues to investigate counterfeit Novo Nordisk A/S's NVO Ozempic (semaglutide) injection of 1 milligram (mg) in the legitimate U.S. drug supply chain and has seized thousands of units of the diabetes drug.
FDA and Novo Nordisk are testing the seized products and do not yet have information about the drugs' identity, quality, or safety.
FDA said the needles from the samples were counterfeit. Accordingly, the sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use counterfeit products.
Other confirmed counterfeit components within the seized products are the pen label, accompanying health care professional and patient information, and carton.
The FDA urged drug distributors, retail pharmacies, healthcare practitioners, and patients to check the drug they received and not distribute, use, or sell the units labeled with lot number NAR0074 and serial number 430834149057.
FDA is aware of five adverse events from this lot, none of which are serious and are consistent with known common adverse reactions to authentic Ozempic, which are nausea, vomiting, diarrhea, abdominal pain, and constipation.
Demand for Wegovy and Ozempic is exceeding Novo's supply of the drugs in the U.S. and certain European countries, leading the company to restrict supplies of specific doses of Wegovy to the U.S. market.
Since the rise in demand for Ozempic and its sister medication, Wegovy, there have been reports of salons and social media distributors selling knockoff versions.
Price Action: NVO shares are down 0.47% at $102.29 during the premarket session on the last check Friday.
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