FDA WARNING_LETTER - Larken Laboratories - December 31, 2009

This FDA Warning Letter, NO. 2010-NOL-03, was issued to Scott Allen, President of Larken Laboratories, on an unspecified date in 2010. It references a prior warning letter issued on (b)(4) 2009 to (b)(4), a manufacturer with whom Larken Laboratories contracted.

The letter states that Larken Laboratories distributes drug products manufactured by (b)(4), including "(b)(4) (each (b)(4) contains: (b)(4))", "(b)(4) Suspension Drops (each (b)(4) contains: (b)(4))", and "(b)(4) Suspension Drops (each (b)(4) contains: (b)(4))".

These products are classified as "new drugs" under Section 201(p) of the Act [21 USC 321(p)] because they are not generally recognized as safe and effective. The FDA asserts that there are no approved applications (NDA/ANDA) on file for these drug products, violating Sections 301(d) and 505(a) of the Act [21 USC 331(a), (d) and 355(a)].

Furthermore, the prescription drug products are deemed misbranded under Section 502(f)(1) of the Act [21 USC 352(