PP_1170x120_10-25-21

Aurobindo gets FDA approval for vigabatrin for oral solution

Print Friendly, PDF & Email

EAST WINDSOR, N.J. – Aurobindo Pharma  has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application vigabatrin for oral solution USP, 500mg. Aurobindo Pharma’s vigabatrin for oral solution USP, 500mg, are an AB-rated generic equivalent to the reference listed drug (RLD), Sabril for Oral Solution of Lundbeck Pharmaceuticals.

Vigabatrin for oral solution is indicated as adjunctive therapy for adults and pediatric patients 10 years of age and older with refractory complex partial seizures. It is also indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age.

Vigabatrin for oral solution has an estimated market size of US $262.5 Million for the twelve months ending July 2021, as per IQVIA.


ECRM-08-202222


Comments are closed.