METAXALONE | N013217 | KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC A SUB OF PFIZER INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition for Reconsideration from Pharmobedient Consulting, LLC FDA-2023-P-5590 Pharmobedient Consulting, LLC filed this petition for reconsideration seeking approval of a suitability petition to submit an ANDA for metaxalone tablets at 600 mg strength, a lower dose than the reference listed drug SKELAXIN at 800 mg. The FDA had denied the original petition citing safety and eff | Suitability | 2024-05-06 | Open | — |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-5590 Pharmobedient Consulting, LLC filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Metaxalone Tablets 600 mg suitable for submission in an Abbreviated New Drug Application, with the reference listed drug being SKELAXIN (M | Suitability | 2023-12-19 | Open | Pharmobedient Consulting |
Citizen Petition from Sovereign Pharmaceuticals LLC FDA-2018-P-1283 Sovereign Pharmaceuticals LLC filed this citizen petition on March 26, 2018, requesting the FDA Commissioner determine whether metaxalone tablets 640 mg (NDA number 022503) was withdrawn for safety or efficacy reasons. The company seeks this determination to enable filing an abbreviated drug applica | 505(q) | 2018-03-27 | Withdrawn | Sovereign Pharmaceuticals LLC |
Citizen Petition from Sovereign Pharmaceuticals, LLC FDA-2016-P-2342 Sovereign Pharmaceuticals, LLC filed an ANDA Suitability Petition under 21 CFR 314.93 requesting permission to submit an abbreviated new drug application for Metaxalone 400 mg and 640 mg tablets, seeking in-vivo bioequivalence testing waivers based on bioequivalence studies using the 800 mg referenc | Other | 2016-08-01 | Withdrawn | Sovereign Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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