indicated for the treatment of partial-onset seizures in patients of four years of age and older.
izures in patients
of four years of age and older.
Alembic
Pharmaceuticals Ltd gets final
approval from the USFDA for its
generic version of Lacosamide
tablet, indicated for the treatment
of partial-onset seizures in
patients of four years of age and
older.
The approval by the US health
regulator is for the abbreviated
new drug application (ANDA) for
Lacosamide tablets of strengths 50 mg, 100 mg, 150 mg, and 200 mg, the
company said in a statement.
The approved ANDA is therapeutically equivalent to the reference listed drug
product Vimpat Tablets -- 50 mg, 100 mg, 150 mg, and 200 mg-of UCB Inc, it