FDA WARNING_LETTER - Vision Pharm, LLC

This FDA Warning Letter, FLA-10-17, dated April 29, 2010, was issued to Sander S. Busman, President & CEO of Vision Pharma, LLC. It references a prior warning letter issued to (b)(4) concerning unapproved new drug products.

The letter identifies several drug products marketed by Vision Pharma, LLC, including Colchicine Tablets, 0.6 mg; Hyoscyamine Sulfate Tablets, USP, 0.125 mg; Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg; and Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg. These products are classified as "new drugs" under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) because they are not generally recognized as safe and effective.

The primary violation is the introduction or delivery into interstate commerce of these new drugs without approved applications, as required by sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)]. The FDA states there are no approved applications on file for these products.

Additionally, these prescription drug products are deemed misbranded under section 502(f)(1) of the Act [21 U.S.