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.
MINOCYCLINE HYDROCHLORIDE | A214934 | NEXUS
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Melinta Therapeutics, LLC FDA-2023-P-0127 Melinta Therapeutics, LLC and its subsidiary Rempex Pharmaceuticals, Inc. filed this citizen petition under 21 U.S.C. § 355 requesting that FDA vacate the July 22, 2022 approval of ANDA 214934 submitted by Nexus Pharmaceuticals, Inc. for a generic minocycline injection product, update its databases | 505(q) Stay Request | 2023-01-11 | Denied | Melinta Therapeutics |
Citizen Petition from Melinta Therapeutics LLC FDA-2021-P-1123 Melinta Therapeutics LLC filed this citizen petition on October 16, 2021, requesting that the FDA refuse to approve ANDA 214934 submitted by Nexus Pharmaceuticals for a generic version of MINOCIN (minocycline) for injection relying on Melinta's NDA 050444 as the reference listed drug, unless Nexus p | 505(q) | 2021-10-19 | Denied | Melinta Therapeutics LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.