FDA WARNING_LETTER - Magna Pharmaceuticals, Inc - December 31, 2009

This FDA Warning Letter, issued to Magna Pharmaceuticals, Inc., addresses violations related to unapproved and misbranded drug products. The letter follows an earlier warning to (b)(4), a manufacturer with whom Magna Pharmaceuticals contracted. Specifically, the firm distributes Ahist Tablets (Chlorpheniramine Tannate), which are deemed "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective. There is no FDA-approved application for this drug product, violating sections 301(d) and 505(a) of the Act. Consequently, the introduction of this product into interstate commerce without an approved new drug application violates sections 301(a) and (d). Additionally, the product is misbranded under section 502(f)(1) because its labeling lacks adequate directions for use, as it is intended for conditions not amenable to self-diagnosis (21 C.F.R. § 201.5). The drug product is also cited as adulterated under 21 U.S.C. 351(a)(2)(B). Magna Pharmaceuticals is responsible for investigating and correcting these violations promptly. Failure to do so may result in legal action, including seizure and injunction, and may impact the firm's eligibility for federal contracts. A written response detailing corrective actions and prevention measures is required within fifteen working days.