FDA WARNING_LETTER - Allegis Pharmaceuticals, LLC - December 31, 2009

This FDA Warning Letter, NO. 2010-NOL-02, issued to Allegis Pharmaceuticals, LLC, on (b)(4) 2009, addresses the distribution of unapproved and misbranded new drug products. The letter follows an FDA inspection of (b)(4) in (b)(4) 2009, where it was found that Allegis Pharmaceuticals contracted with (b)(4) to manufacture drug products for distribution.

The identified drug products, including (b)(4) suspension, (b)(4) suspension, (b)(4) suspension, and (b)(4) tablets, are classified as "new drugs" under Section 201(p) of the Act because they are not generally recognized as safe and effective. These products lack FDA-approved applications, violating Sections 301(d) and 505(a) of the Act [21 USC 331(a), (d) and 355(a)].

Furthermore, these prescription drug products are misbranded under Section 502(f)(1) of the Act [21 USC 352(f)(1)] because their labeling fails to bear adequate directions for use by laypersons, as required by 21 CFR 201.5. They are not exempt from this requirement under 21 CFR 201.115.