VIGABATRIN | N020427 | LUNDBECK PHARMACEUTICALS LLC
| 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 |
Citizen Petition from Sidley Austin, LLP FDA-2023-P-4896 · 5 docket documents Sidley Austin LLP filed this citizen petition on behalf of a client requesting that the FDA refrain from granting orphan drug exclusivity to vigabatrin oral solution (PYR-003) developed by Pyros Pharmaceuticals for treatment of infantile spasms, arguing that Pyros cannot demonstrate clinical superio | Other | 2023-11-06 | Withdrawn | Sidley Austin, LLP |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process, formulation, or other pharmaceutical development aspects to support regulator | Suitability | 2022-02-23 | Withdrawn | Upadhye Tang, LLP |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.
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