Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
VONOPRAZAN FUMARATE | N218710 | PHATHOM PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Phathom Pharmaceuticals, Inc. FDA-2024-P-5703 Phathom Pharmaceuticals, Inc. filed this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA correct the Orange Book to accurately reflect a full ten-year period of new chemical entity exclusivity for VOQUEZNA (vonoprazan tablets, approved under NDA | 505(q) | 2024-12-11 | Granted | Phathom Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.