SUVOREXANT | N204569 | MERCK SHARP AND DOHME CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Amendment from APDM Pharmaceuticals Private Limited FDA-2026-P-1300 APDM Pharmaceuticals Private Limited submitted an amendment to a suitability petition under 21 CFR 505B requesting a waiver of pediatric assessment requirements under the Pediatric Research Equity Act for suvorexant (BELSOMRA) tablets in preparation for filing an ANDA. The petitioner argues that ped | Suitability | 2026-02-27 | Open | — |
Suitability Petition from APDM Pharmaceuticals Private Limited FDA-2026-P-1300 APDM Pharmaceuticals Private Limited filed this citizen petition pursuant to 21 CFR § 314.93 and section 505(j)(2)(c) of the FDC Act requesting FDA approval to submit an abbreviated new drug application for suvorexant capsules in dosages of 5 mg, 10 mg, 15 mg, and 20 mg, which would differ from the | Suitability | 2026-02-05 | Open | APDM Pharmaceuticals Private Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.