RESPONSE LETTER
Niche Pharmaceuticals, Inc
- Company:
- Niche Pharmaceuticals, Inc
580 Commerce St.
Ste. 100
Southlake, TX 76092-9156
United States- 817-421 -2777
- Recipient:
- Dana Lewis
- Compliance Officer
United States
Dear Ms. Lewis,
This letter is a follow-up to our discussion regarding the Warning Letter received by Niche Pharmaceuticals, Inc. on July 19, 2018. Case 553911. Pursuant to the Agency's request Niche Pharmaceuticals, Inc. has reformulated its product Mag-Tab SR to remove yellow dye #10 from the formulation. The caplet now contains "(b)(4) white" which is approved for dietary supplements as a colorant. As allowed by the CFSAN, all existing yellow caplets were sold by about April 1, 2019. All current inventory and sales are now yellow dye free and are white coated caplets.
Further to the Warning Letter, we edited our website shortly after receiving the letter to remove the few items cited as drug claims in the Metabolic section as well as a few testimonials.
As such we are requesting the FDA to update their action with a follow-up letter stating that Niche Pharmaceuticals, Inc. is "in compliance" with the stated Warning Letter demands.
Sincerely,
/S/
Stephen F. Brandon Sr. - CEO
Niche Pharmaceuticals, Inc.