Nalpropion Pharmaceuticals LLC

CLOSEOUT LETTER Nalpropion Pharmaceuticals LLC MARCS-CMS 610942 — May 10, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Recipient Name Aaron Chesnut Recipient Title Vice President, Technical Operations Nalpropion Pharmaceuticals LLC 155 Franklin Road Suite 450 Brentwood , TN 37027 United States Issuing Office: The Office of Prescription Drug Promotion (OPDP) United States Dear Aaron Chesnut: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated September 22, 2020. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA surveillance 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 subsequent surveillance or through other means. If you have any questions or comments, please direct your response to the undersigned at the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266. A courtesy copy can be sent by facsimile to (301) 847-8444. Please refer to MA 516 in addition to the NDA number in all future correspondence relating to this particular matter. All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. You are encouraged, but not required, to submit your response in eCTD format. All correspondence submitted in response to this letter should be placed under eCTD Heading 1.15.1.6. Questions related to the submission of your response letter should be emailed to the OPDP RPM at CDER-OPDP-RPM@fda.hhs.gov. Sincerely, {See appended electronic signature page} Meena Savani Regulatory Review Officer Division of Advertising & Promotion Review 2 Office of Prescription Drug Promotion -------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record. -------------------------------------------------------------------------------------------- /s/ ------------------------------------------------------------ MEENA R SAVANI 05/10/2023 01:15:41 PM Content current as of: 05/10/2023 Regulated Product(s) Drugs