ERIBULIN MESYLATE | N201532 | EISAI INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3 - ERIBULIN MESYLATE injection, for intravenous use RE Suitabilit... FDA-2023-P-5135 Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding Eribulin Mesylate injection for intravenous use, requesting FDA guidance on the regulatory pathway and requirements for developing a generic version of this product. | Suitability | 2023-11-20 | Open | Hyman |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2023-P-5135 The law firm Hyman, Phelps & McNamara, P.C., filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Eribulin Mesylate Injection in 2 mg/4 mL and 2.5 mg/5 mL strengths suitable for submission as an ANDA | Suitability | 2023-11-20 | Open | Hyman |
Attachment 2 - HALAVEN- eribulin mesylate injection RE Suitability Petition f... FDA-2023-P-5135 Hyman, Phelps & McNamara, P.C. filed a suitability petition regarding HALAVEN (eribulin mesylate injection), requesting FDA evaluation of the product's suitability for regulatory purposes under applicable standards. | Suitability | 2023-11-20 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| RE46965 | Jan 8, 2027PED: Jul 8, 2027 | PED | — | Yes | — | — |
| Code | Date | Status |
|---|---|---|
| M-280 | Sep 13, 2025 | Expired |
| PED | Mar 13, 2026 | Expired |