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Kirkman Laboratories, Inc. MARCS-CMS 473118 —

Delivery Method:
UPS Overnight Delivery

Recipient Name
Anthony L. Young
Kirkman Laboratories, Inc.

1850 M Street N.W. Suite 800
Washington, DC 20036-5120
United States

Issuing Office:
Seattle District

22215 26th Avenue SE, Suite 210
Bothell, WA 98021
United States

Anthony L. Young
Peter R. Mathers
Kleinfeld, Kaplan & Becker, LLP
1850 M Street N.W. Suite 800
Washington, DC 20036-5120

Dear Mr. Young and Mr. Mathers:

This letter acknowledges receipt of your letter dated February 3, 2016, in which you responded on behalf of Kirkman Laboratories ("Kirkman") to FDA's January 13, 2016 Warning Letter (reference SEA 16-07).

We have completed our evaluation of the information you provided regarding the marketing of Kirkman's prescription fluoride products described in the January 2016 Warning Letter and find your response adequate. Based on a reevaluation of the information available to FDA, we have decided not to take action to remove these unapproved products from the market at this time.

As stated in the Warning Letter, the appropriate pathway to lawfully market Kirkman's unapproved prescription drugs is to obtain FDA approval, and we encourage firms to pursue regulatory approval. Please note that depending on the enforcement priorities of the Agency as articulated in its policy, FDA's policy document entitled, "Marketed Unapproved Drugs-Compliance Policy Guide, Sec 440.100 - Marketed New Drugs without Approved NDAs or ANDAs" dated September 19, 2011(1)(CPG), the Agency may seek to take action against these drug products at a future time.

Thank you for your attention to this matter.

Miriam R. Burbach
District Director

1 See http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070290.pdf.


Mr. David K. Humphrey, President and CEO
Kirkman Laboratories, Inc.
6400 Rosewood St.
Lake Oswego, Oregon 97035

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