William Wynne – FDA Warning Letter
The FDA issued a Warning Letter to Andersen Pharmacy and Duke Pharmacy for offering violative products for sale on their websites, andersenpharmacy.com and dukepharmacy.com, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The products identified as violative include "Acomplia (Brand)," "Acomplia (Generic)," "Rimonabant," "Herbal Ambien," "Herbal Xanax," "Valium (Brand)," "Valium (Generic)," and "Prozac (Generic)." These products are classified as drugs under section 201(g) of the Act.
The violations include: 1. **Unapproved New Drugs:** Products such as "Acomplia (Brand)," "Acomplia (Generic)," "Rimonabant," "Herbal Ambien," and "Herbal Xanax" are unapproved new drugs. Rimonabant (Acomplia) was specifically rejected by the FDA due to safety concerns, including neurological and psychiatric side effects. "Herbal Ambien" and "Herbal Xanax" are also considered new drugs due to their intended use. The sale of these products without FDA-approved applications violates sections 301(d) and 505(a) of the Act. 2. **Misbranded Drugs:** * Products like "Valium (Brand)," "Valium (Generic)," and "Prozac
- Company
- William Wynne
- Product type
- Drugs
ID · 591d035e-9c45-47a7-8156-8380d9ad7c0a
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