Amherst Pharmaceuticals, LLC/Magna Pharmaceuticals, Inc.

CLOSEOUT LETTER Amherst Pharmaceuticals, LLC/Magna Pharmaceuticals, Inc. April 24, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: TRANSMITTED BY FACSIMILE Product: Drugs Recipient: Recipient Name Warren P. Lesser, DBA, MBA Recipient Title President/CEO Amherst Pharmaceuticals, LLC/Magna Pharmaceuticals, Inc. 10801 Electron Drive, Suite 100 Louisville , KY 40299 United States Issuing Office: The Office of Prescription Drug Promotion (OPDP) United States RE: NDA 022196 Zolpimist (zolpidem tartrate) Oral Spray (C-IV) RE: NDA 022196 Zolpimist (zolpidem tartrate) Oral Spray (C-IV) MA 9 Dear Dr. Lesser: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated November 14, 2017. 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 9 in addition to the NDA number in all future correspondence relating to this particular matter. OPDP reminds you that only written communications are considered official. Sincerely, {See appended electronic signature page} Christine Bradshaw, PharmD, RAC Regulatory Review Officer Division of Advertising & Promotion Review 1 Office of Prescription Drug Promotion cc: Suzane Kelderman – CMQ/OE Director of Regulatory Affairs and Quality Assurance Aytu BioScience, Inc. 373 Inverness Parkway, Suite 206 Englewood, CO 80112 -------------------------------------------------------------------------------------------- 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/ ------------------------------------------------------------ CHRISTINE J BRADSHAW 04/24/2019 02:21:02 PM Content current as of: 04/24/2019 Regulated Product(s) Drugs