| 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 |
