Lupin's Eslicarbazepine Acetate Tablets Secures US FDA Approval

The leading global pharmaceutical company Lupin Limited (Lupin) revealed that it had been authorized by the United States Food and Drug Administration (FDA) to provide an abbreviated new drug application (ANDA) for the formulation of an active pharmaceutical ingredient (API), namely eslicarbazepine acetate tablets in the dosages as 200 mg, 400.

Penicillin[ANDA]olic was among the first applicants and can take the lead of 180 days of shared generic exclusivity. The item will be produced by the Lupin plant located in Pithampur, India.

Eslicarbazepine acetate tablets are indicated for partial-onset seizures in adults and children over four years of age (pediatric-use information).

Eslicarbazepine acetate tablets (RLD Aptiom) were estimated to have USD 354 million in annual sales in the United States, according to IQVIA MAT (January 2024).

Lupin is a Mumbai-based transnational biomedical company that is defined by an innovation and development policy. The organization puts together and sells its branded as well as generic formulated products, biological products, and APIs in around 100 markets in the US, India, South Africa, and in regions of the Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.