SELENIOUS ACID | N209379 | AMERICAN REGENT INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| FLMD | 2025-06-06 | Terminated 2025-06-24 | — | |
| D.N.J. | 2025-05-16 | Terminated 2025-08-05 | — | |
American Regent, Inc. v. Meitheal Pharmaceuticals, Inc. et al 2 patentsANDA 219472Selenious Acid | D. Del. | 2025-02-14 | Terminated 2025-02-26 | — |
AMERICAN REGENT, INC. v. MEITHEAL PHARMACEUTICALS, INC. et al 2 patentsANDA 219472Selenious Acid | D.N.J. | 2025-02-14 | Terminated 2025-02-21 | — |
| D.N.J. | 2024-07-16 | Terminated 2025-12-09 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3 - SELENIOUS ACID- selenious acid injection, solution RE Suitabil... FDA-2023-P-4465 Pharmobedient Consulting, LLC filed a suitability petition regarding selenious acid injection, solution, requesting FDA determination on the suitability of the product for approval through the abbreviated new drug application (ANDA) pathway or other appropriate regulatory mechanisms. | Suitability | 2023-10-11 | Open | Pharmobedient Consulting |
Attachment 4 - Draft Guidance on Selenious Acid RE Suitability Petition from ... FDA-2023-P-4465 Pharmobedient Consulting, LLC filed a petition requesting FDA guidance on the regulatory suitability of selenious acid as a pharmaceutical ingredient. The petition seeks clarification through draft guidance documentation to establish the regulatory pathway and acceptability standards for selenious a | Suitability | 2023-10-11 | Open | Pharmobedient Consulting |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4465 Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the FDC Act and 21 CFR 314.93 requesting FDA approval to submit an ANDA for Selenious Acid Injection at lower strengths of 400 mcg/10 mL and 8 mcg/2 mL compared to the reference listed drug approved by Americ | Suitability | 2023-10-11 | Open | Pharmobedient Consulting |
Attachment 2 - SELENIOUS ACID- selenious acid injection, solution RE Suitabil... FDA-2023-P-4465 Pharmobedient Consulting, LLC filed a suitability petition regarding selenious acid injection, solution, requesting FDA evaluation of the drug's suitability for approval or regulatory status determination. | Suitability | 2023-10-11 | Open | Pharmobedient Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.