Noven Pharmaceuticals, Inc.

CLOSEOUT LETTER Noven Pharmaceuticals, Inc. MARCS-CMS 479136 — April 21, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Noven Pharmaceuticals, Inc. United States Issuing Office: United States Office of Pharmaceutical Quality Operations, Division 2 4040 N. Central Expressway, Suite 300 Dallas, Texas 75204 April 21, 2018 VIA UPS OVERNIGHT Mr. Jeff Mihm, President and CEO Noven Pharmaceuticals Inc. 11960 S.W. 144th Street Miami, Florida 33186-6109 Mr. Mihm: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (FLA-16-21) dated August 5, 2016. Based on our evaluation during the January 18, 2018 through January 26, 2018 inspection of your firm, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. If you have any questions regarding this letter, you may contact Jose R. Lopez at JoseR.Lopez@fda.hhs.gov or by phone at (787) 729-8603 . In addition, you may contact me at (214) 253-5288 . Sincerely, /S/ LCDR John W. Diehl, M.S. Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division II Content current as of: 04/24/2018