
Lupin Limited obtained approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) concerning Eslicarbazepine Acetate Tablets, available in 200 mg, 400 mg, 600 mg, and 800 mg strengths. These tablets serve as a generic equivalent to Aptiom Tablets, and are indicated for the treatment of partial-onset seizures in patients aged 4 years and older. Lupin's manufacturing facility in Pithampur, India, will produce the approved product. Being among the initial ANDA applicants, Lupin may qualify for 180 days of shared generic exclusivity.
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