Clarke Pharmaceutical Manufacturing, Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

There are no approved applications under section 505 for your “OsteoBLAST®,” “Cell Block #19,” “High Potency Vitamin D3,” “Neupanex®,” and “Natural Progesterone Skin Cream” products. Accordingly, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the Act, 21 U.S.C 355(a) and 331(d).

Passage 2

Your “OsteoBLAST®,” “Cell Block #19,” “High Potency Vitamin D3,” “Neupanex®,” and “Natural Progesterone Skin Cream” products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, “OsteoBLAST®,” “Cell Block #19,” “High Potency Vitamin D3,” “Neupanex®,” and “Natural Progesterone Skin Cream” products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)].