FDA WARNING_LETTER - New Horizons LTD

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Record Details

The FDA issued a Warning Letter to the operators of multiple websites, including topdrugstore.net and us-rx-meds.com, for offering violative drug products for sale. The products, such as "Acomplia (Generic)," "Acomplia (Brand)," "Rimonabant," "Viagra (Brand)," "Cialis (Brand)," "Prozac (Generic)," and "Levitra (Brand)," are considered drugs under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act).

The firm is in violation of the Act for marketing and distributing unapproved new drugs. Specifically, "Acomplia (Generic)," "Acomplia (Brand)," and "Rimonabant" are unapproved new drugs as defined by section 201(p) and their sale violates sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a). Rimonabant was previously rejected for FDA approval due to safety concerns, including neurological and psychiatric side effects.

Additionally, many products, including "Viagra (Brand)," "Cialis (Brand)," "Prozac (Generic)," and "Levitra (Brand)," are misbranded under section 503(b)(1) of the Act, 21 U.S.C

Company: New Horizons LTD
Product Type: Drugs
Office: Center for Drug Evaluation and Research
People: Deborah M. Autor (Former FDA Deputy Commissioner)
Chris Walsh
John Ruben
Gordon Mcleod
Piter Krasnikov

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ID · aa90b703-fb82-4f67-b866-edb42eef7411

Violation Codes9

21 U.S.C. 353(b)(1)21 U.S.C. 321(g)21 U.S.C. 321(p)21 U.S.C. 331(d)21.U.S.C. 355(a)21 U.S.C. 331(b)21 U.S.C. 331(k)21 U.S.C. 352(a)21 U.S.C. 331(a)

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