SABRIL

FDA-2023-P-5209

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.

FDA-2023-P-5209

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

FDA-2023-P-5209

Upadhye Tang LLP filed a suitability petition regarding vigabatrin, seeking FDA confirmation that the proposed product information and formulation are suitable for commercial development and approval as a new drug application (NDA) or abbreviated new drug application (ANDA).

FDA-2022-P-0214

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

FDA-2022-P-0214

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