VIGABATRIN | N022006 | LUNDBECK PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Upadhye Tang LLP FDA-2023-P-5209 · 8 docket documents Shashank Upadhye of Upadhye Tang LLP filed this suitability petition on November 26, 2023, requesting that the FDA determine whether Vigabatrin for oral solution containing 25 grams per bottle or sachet is suitable for submission as an Abbreviated New Drug Application based on the reference listed d | 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for treatment of infantile spasms, arguing that Pyros cannot demonstrate clinical superio | Other | 2023-11-06 | Withdrawn | Sidley Austin, LLP |
Suitability Petition from Upadhye Tang, LLP FDA-2022-P-0214 · 7 docket documents Upadhye Tang LLP filed this suitability petition on behalf of an unnamed client requesting that the FDA determine whether Vigabatrin for oral solution in a 25 g/bottle strength is suitable for submission in an ANDA, representing a change in strength from the reference listed drug Vigabatrin for oral | Suitability | 2022-02-23 | Withdrawn | Upadhye Tang, LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.