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Aurobindo Pharma receives US FDA tentative approval for Lacosamide tabs

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Lacosamide tablets are the generic equivalent of USB’s Vimpat tablets and used in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older

Aurobindo Pharma announced that US Food & Drug Administration (US FDA) has granted the tentative approval for Lacosamide tablets 50mg, 100mg, 150mg and 200mg (ANDA 204994). Lacosamide tablets are the generic equivalent of USB’s Vimpat tablets and used in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older with a market size of approximately $593 million for the twelve months ending January 2015 according to IMS.

This ANDA contains a Paragraph IV certification and is currently under litigation in the United States District Court for the District of Delaware [UCB, UCB Pharma GMBH Research Corporation Technologies and Harris FRC Corporation v. Aurobindo Pharma and Aurobindo Pharma USA, Civil Action No 1:13-cv-01210-UNA].

Aurobindo now has a total of 193 ANDA approvals (165 final approvals and 28 tentative approvals) from the US FDA.

EP News Bureau Mumbai

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