The approval by the US Food and Drug Administration is for Vigabatrin tablets of 500 mg strength, Cadila Healthcare said in a regulatory filing.
Cadila Healthcare Ltd on Thursday said group firm Zydus has received final approval from the US health regulator to market its generic version of Vigabatrin tablets to treat babies with infantile spasms and epilepsy in combination with other medications.
The approval by the US Food and Drug Administration is for Vigabatrin tablets of 500 mg strength, Cadila Healthcare said in a regulatory filing.
The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad, it added.
The company said Vigabatrin is used to treat babies, one month to 2 years old, with infantile spasms. It is also used in combination with other medications to treat seizure disorders (epilepsy).
Vigabatrin decreases the number of seizures in adults and children who have not been able to control their seizures with other treatments. Vigabatrin is an anticonvulsant. It is known to work by stopping the breakdown of a natural calming substance (GABA) in the brain.
The group now has 326 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.