VIGABATRIN | N217684 | PYROS PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 3_ vigabatrin-proposed-product-pi-clean re: Suitability Petition f... FDA-2023-P-5209 · 8 docket documents Upadhye Tang LLP filed a suitability petition regarding vigabatrin, seeking FDA determination of whether the drug is suitable for development as an abbreviated new drug application (ANDA). The petition requests that FDA confirm vigabatrin's eligibility for generic development under the ANDA pathway. | Suitability | 2023-11-27 | Denied | Upadhye Tang LLP |
Attachment 2 - SABRIL- vigabatrin powder, for solution Lundbeck Pharmaceutica... FDA-2022-P-0214 · 7 docket documents Upadhye Tang LLP filed a suitability petition on behalf of Lundbeck Pharmaceuticals LLC regarding SABRIL (vigabatrin powder for solution), requesting FDA evaluation of the suitability of the proposed manufacturing process, formulation, or other pharmaceutical development aspects to support regulator | Suitability | 2022-02-23 | Withdrawn | Upadhye Tang, LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.