Frequently requested or proactively posted drug-specific and other rec

4/1/2026 Letter on Hemp-Derived Cannabidiol Products in Medical Research Models (PDF – 212 KB)  2/24/2025 Product Resolution of Tirzepatide Injection Shortage and Supply Status (PDF – 1.103 KB) 5/21/2024 Drug Approval Package: JAYPIRCA 11/9/2023 First Interchangeable Exclusivity Expiration Memorandum for Cyltezo October 3, 2023 (PDF – 1.41MB) 5/15/2023 Adverse event report for Syfovre (PDF – 126KB) 5/19/2022 Epidemiology Review: Consumer Opioid Disposal Literature Scan and Search Results (dated April 29, 2021) (PDF – 569KB) 7/31/2020 FDA Letter to USP:  Reporting Threshold in USP-NF Monographs 6/30/2020 COVID-19 Related Records 5/20/2020 Exclusivity Summary for Testosterone undecanoate (oral) (dated August 6, 2019) (PDF – 110KB) 5/20/2020 Exclusivity Summary for Testosterone undecanoate (oral) (dated March 27, 2019) (PDF – 50KB) 8/5/2019 Additional Information on Transmucosal Immediate Release Fentanyl (TIRF) REMS 2/25/2019 Additional Information on Extended-Release (ER) and Long-Acting (LA) Opioid Analgesics REMS 5/3/2019 Decision to waive the requirement for a single, shared system REMS program for ambrisentan tablet products (dated March 22, 2019) (PDF – 61KB) 2/25/2019 TIRF FDA Memo on REMS Modification (10-31-2013) (PDF – 166KB) 2/25/2019 TIRF FDA Memo on REMS Modification (6-1-2012) (PDF – 91KB) 2/25/2019 ERLA Six-Month Assessment Report (PDF – 2.91MB) 9/26/2018 Adverse Event Reports for Pharmacovigilance Review of INSTIs and NTDs plus Spinal Malformations 6-13-18 (PDF – 1.16MB) 9/26/2018 Pharmacovigilance Review of INSTIs and NTDs plus Spinal Malformations 6-13-18 (PDF – 1.57MB) 3/28/2018 FDA Letter to USP: Drug Product Monographs for Biological Products (PDF – 609KB) 3/6/2018 Kratom additional death adverse event reports (PDF – 1MB) 2/9/2018 Decision to waive the requirement for a single, shared system REMS program for alosetron hydrochloride products (dated April 30, 2015) (PDF – 277KB) 2/6/2018 Adverse event reports regarding Kratom that resulted in death (PDF – 7MB) 8/31/2017 Additional Information NDA 206488 Exondys 51 (eteplirsen) Approval 3/27/2017 Teething Tablet Adverse Event Reports Part 1 of 3 (PDF – 57MB) 3/27/2017 Teething Tablet Adverse Event Reports Part 2 of 3 (PDF – 89MB) 3/27/2017 Teething Tablet Adverse Event Reports Part 3 of 3 (PDF – 22MB) 2/8/2017 Exclusivity Determination Memorandum for Morphabond (morphine sulfate) extended-release tablets for NDA 206544, (dated 11/16/16) (PDF – 420KB) 1/25/2017 Decision to waive the requirement for a single, shared system REMS for sodium oxybate oral solution (dated January 17, 2017) (PDF – 1.77MB) 9/27/2016 Recommendation to maintain marijuana in Schedule I of the Controlled Substances Act [Date Range May – June 2015] (PDF – 57MB

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