STAT+: Novo Nordisk is warned by the FDA for failing to report side effects

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Source: STAT News

Original: https://www.statnews.com/pharmalot/2026/03/10/novo-failed-report-side-effects-fd...

Published: Tue, 10 Mar 2026 14:51:35 +0000

The FDA warned Novo Nordisk for improper side effect reporting practices.[1] This is the third time in recent weeks that the FDA has reprimanded Novo Nordisk.[1] Additionally, the FDA sent warning letters to 30 telehealth firms for making misleading claims about compounded versions of GLP-1 drugs, including Novo Nordisk's semaglutide.[2] These companies labeled the products as "generic Zepbound" or "generic Mounjaro" without indicating that they were compounded drugs.[2] The FDA emphasized that compounded drugs are not approved and are not the same as generics.[2] Companies must respond in writing within 15 working days.[2] This is the second wave of warning letters since September, with the FDA sending thousands in the past six months, more than in the entire previous decade.[2] Shares of Novo Nordisk fell nearly 1% after the FDA warned about misleading claims in advertising for Ozempic.[4]