VIGABATRIN | A210196 | AUCTA PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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for treatment of infantile spasms, arguing that Pyros cannot demonstrate clinical superio | Other | 2023-11-06 | Withdrawn | Sidley Austin, LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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