Hunter, D – FDA Warning Letter
The FDA issued a Warning Letter to medspricedright.com and valuedrugspharmacy.com for offering violative drug products for sale. The products include "Acomplia (Brand)," "Rimonabant," "Herbal Ambien," "Ambien (Brand)," "Valium (Brand)," and "Xanax (Brand)."
The identified violations include the sale of unapproved new drugs. "Acomplia (Brand)" and "Rimonabant" are unapproved new drugs under sections 201(p) and 505(a) of the Act, 21 U.S.C. §§ 321(p) and 355(a), as Rimonabant was rejected for FDA approval due to safety concerns. "Herbal Ambien" is also an unapproved new drug under section 201(p) of the Act. The sale of these products without FDA-approved applications violates sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a).
Additionally, the websites are selling misbranded drugs. "Ambien (Brand)," "Valium (Brand)," and "Xanax (Brand)" are offered without requiring a prescription from a licensed practitioner, violating section 503(b)(1)
- Company
- Hunter, D
- Product type
- Drugs
ID · f66d3d00-ab1d-4ef3-b0c1-bc19f588653c
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