Lupin Gets USFDA Nod For Generic Medication
The company has received a nod from the U.S. Food and Drug Administration to market Eslicarbazepine Acetate tablets in strengths of 200 mg, 400 mg, 600 mg, and 800 mg, Lupin Ltd. said in a statement..
Drug maker Lupin on Thursday said it has received approval from the U.S. health regulator to market a generic medication for the treatment of seizures.
The company has received a nod from the U.S. Food and Drug Administration to market Eslicarbazepine Acetate tablets in strengths of 200 mg, 400 mg, 600 mg, and 800 mg, Lupin Ltd. said in a statement.
The Mumbai-based company's product is a generic equivalent of Sumitomo Pharma America Inc's Aptiom tablets, it added.
Lupin said it is one of the first abbreviated new drug application (ANDA) applicants and may be eligible for 180 days of shared generic exclusivity.
Eslicarbazepine Acetate tablets are indicated for the treatment of partial-onset seizures in patients of four years of age and above.
As per IQVIA MAT January 2024 data, Eslicarbazepine Acetate tablets had estimated annual sales of $354 million in the U.S.