Metuchen Pharmaceuticals, LLC

CLOSEOUT LETTER Metuchen Pharmaceuticals, LLC MARCS-CMS 590713 — September 18, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: NDA 202276 Product: Drugs Recipient: Recipient Name Fady Boctor Metuchen Pharmaceuticals, LLC 200 US Hwy 9 Suite 500 Manalapan , NJ 07726 United States Issuing Office: Office of Prescription Drug Promotion United States Dear Mr. Boctor: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated August 16, 2019. 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 . To ensure timely delivery of your submissions, please use the full address above and include a prominent directional notation (e.g. a sticker) to indicate that the submission is intended for OPDP. Please refer to MA 169, 182, 187 in addition to the NDA number in all future correspondence relating to this particular matter. Sincerely, {See appended electronic signature page} Elvy Varghese, PharmD Regulatory Review Officer Division of Advertising & Promotion Review 2 Office of Prescription Drug Promotion Cc: Nicol George, PharmD Executive Director, Regulatory & Medical Review Services OneSource Regulatory LLC PO Box 1047 Libertyville, IL 60048 -------------------------------------------------------------------------------------------- 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/ ------------------------------------------------------------ ELVY M VARGHESE 09/18/2020 10:03:33 AM Content current as of: 03/11/2021 Regulated Product(s) Drugs