FDA WARNING_LETTER - Accentia Biopharmaceuticals, Inc

This FDA Warning Letter, FLA-10-04, dated November 13, 2009, was issued to Accentia Biopharmaceuticals, Inc., following a previous warning letter to (b)(4). The letter identifies several drug products, including (b)(4), (b)(4), (b)(4), and (b)(4), as unapproved new drugs. These products are deemed "new drugs" under Section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their intended uses.

A key violation is the introduction or delivery of these products into interstate commerce without approved New Drug Applications (NDAs), as required by Sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)]. Additionally, these 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, and are not exempt from this requirement. The letter also states these products are adulterated under 21 U.S.C. 351(a)(2)(B).

Accentia Biopharmaceuticals