METAXALONE | N022503 | PRIMUS PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition for Reconsideration from Pharmobedient Consulting, LLC FDA-2023-P-5590 · 11 docket documents 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 | Denied | — |
Citizen Petition from Sovereign Pharmaceuticals LLC FDA-2018-P-1283 · 5 docket documents 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on March 26, 2018, requesting the FDA Commissioner determine whether metaxalone tablets 640 mg (NDA number 022503) was withdrawn for safety or efficacy reasons.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 | Granted | Sovereign Pharmaceuticals LLC |
Citizen Petition from Sovereign Pharmaceuticals, LLC FDA-2016-P-2342 · 6 docket documents 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in-vivo bioequivalence testing waivers based on bioequivalence studies using the 800 mg referenc | Other | 2016-08-01 | Withdrawn | Sovereign Pharmaceuticals, LLC |
Mutual Pharmaceutical Company, Inc. FDA-2001-P-0001 · 4 docket documents Mutual Pharmaceutical Company, Inc. filed this citizen petition on March 6, 2001, requesting that the FDA withhold approval of any abbreviated new drug application (ANDA) for generic metaxalone tablets (Skelaxin, 400 mg) unless accompanied by an acceptable in-vivo fasting bioequivalence study, and f | 505(q) | 2012-04-25 | Granted | — |
Mutual Pharmaceutical Company, Inc. - Citizen Petition FDA-2009-P-0223 · 6 docket documents Mutual Pharmaceutical Company, Inc. filed this citizen petition under 21 CFR §10.30 requesting that the FDA declare Skelaxin (metaxalone) 800 mg tablets misbranded and require King Pharmaceuticals to update its NDA labeling to reflect that Skelaxin is a delayed release dosage form, update the dosage | 505(q) | 2009-05-18 | Denied | — |
Mutual Pharmaceutical Company - Citizen Petition FDA-2007-P-0017 · 7 docket documents Mutual Pharmaceutical Company filed this citizen petition on July 27, 2007, requesting that the FDA require labeling changes for Skelaxin (metaxalone) to include information about the drug's metabolism by specific P450 liver enzymes (CYP1A2, CYP2D6, CYP2E1, and CYP3A4) and potential interactions wit | 505(q) | 2008-06-19 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.