Drugs

2 Unapproved GLP-1 Drug Marketers Warned: FDA

FDA has sent Warning Letters to two online marketers promoting unapproved glucagon-like peptide-1 receptor agonists semaglutide (Novo Nordisk’s diabetes and weight-loss drug under trade names Ozembic and Wegovy) and tirzepatide (Eli Lilly’s Mounjaro). “There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs,” the agency said in its letters. “Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight.”

One letter was sent to www.gorillahealing.com for offering separately unapproved semaglutide and tirzepatide. The other letter was sent to www.semaspace.com for marketing unapproved semaglutide.

The letters told the marketers to respond within 15 working days describing the specific steps taken to address any violations and to prevent their recurrence.

2 Unapproved GLP-1 Drug Marketers Warned: FDA

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