METAXALONE | N013217 | KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC A SUB OF PFIZER INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-5590 · 11 docket documents 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 | Denied | Pharmobedient Consulting, 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in-vivo bioequivalence testing waivers based on bioequivalence studies using the 800 mg referenc | Other | 2016-08-01 | Withdrawn | Sovereign Pharmaceuticals, LLC |
CorePharma, LLC - Citizen Petition FDA-2013-P-1199 · 4 docket documents CorePharma, LLC filed this citizen petition requesting that the FDA determine whether the discontinued Skelaxin 400 mg tablet (metaxalone, NDA 013217, manufactured by King Pharmaceuticals) was withdrawn from the market for reasons other than safety or effectiveness, to permit approval of a generic a | Other | 2013-10-25 | Denied | — |
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.
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