FDA WARNING_LETTER - Victory Pharma Inc

The FDA issued a Warning Letter to Victory Pharma, Inc. on November 13, 2009, following information obtained during an inspection of a manufacturer, (b)(4), with whom Victory Pharma contracted. The letter identifies that Victory Pharma marketed unapproved new drugs, specifically (b)(4) and (b)(4), which are intended for disease treatment and lack FDA-approved applications under sections 505(b) or (j) of the Federal Food, Drug, and Cosmetic Act (the "Act").

These products are deemed "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective. Their introduction into interstate commerce without approved applications violates sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)].

Furthermore, the prescription drug products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] because they lack adequate directions for use by a layman, as required by 21 C.F.R. § 201.5, and are not exempt under 21 C.F.R. § 201.115 due to the absence of approved applications. The products