AstraZeneca Pharmaceuticals LP

CLOSEOUT LETTER AstraZeneca Pharmaceuticals LP MARCS-CMS 664789 — May 29, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: NDA 212122 Product: Drugs Recipient: Recipient Name Inna Kissen, Ph.D. Recipient Title Senior Director, Promotional Regulatory Affairs AstraZeneca Pharmaceuticals LP 1800 Concord Pike Wilmington , DE 19850 United States Issuing Office: The Office of Prescription Drug Promotion (OPDP) United States Secondary Issuing Offices United States Dear Dr. Kissen: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated August 4, 2023. 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 385 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. Additionally, the response submission should be coded as an Amendment to eCTD Sequence 0560 under NDA 212122. Questions related to the submission of your response letter should be emailed to the OPDP RPM at CDER-OPDPRPM@fda.hhs.gov. Sincerely, {See appended electronic signature page} Kyle Snyder, PharmD 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/ ------------------------------------------------------------ KYLE SNYDER 05/29/2024 09:53:15 AM Content current as of: 05/31/2024 Regulated Product(s) Drugs