FDA warning letter targets online seller of unapproved semaglutide injection
The Sept. 24 letter says Cheap Medicine Shop sold "Semanext Injection" to U.S. consumers online without prescription, a product with no FDA application on file.
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By Daniel Okafor · Regulatory Correspondent
Oct 14 12:38 ETSource: Coalition For A Prosperous America
The wire
- 01FDA warned India-based online retailer Cheap Medicine Shop on Sept. 24 for marketing unapproved and misbranded injectable semaglutide, sold as Semanext, directly to American buyers without a prescription.
- 02The action marks continued federal attention on cross-border GLP-1 supply; FDA notes unapproved injectables may be contaminated, counterfeit or contain incorrect active ingredient amounts.
- 03Warning letters do not automatically trigger seizures or import bans. The Semanext brand is associated with Zydus and licensed by Lupin, though FDA did not name either company in the letter.
From the source
Read at prosperousamerica.orgFDA Warns Online Sellers Over Unapproved Semaglutide Injections Marketed Under Indian Drugmakers' Brands
As Capitol Hill debates what the future of the U.S. generic drugs industry will look like, another alarm bell has rung at the Food and Drug Administration (FDA). This time, imported semaglutide generics – similar to Ozempic – sold by a company called the Cheap Medicine Shop were issued an FDA Warning Letter for marketing a drug that had not been approved for sale in the U.S.
