Aurobindo Pharma announced that US Food & Drug Administration (USFDA) has granted the tentative approval for Lacosamide Tablets 50mg, 100mg, 150mg and 200mg (ANDA 204994).
Lacosamide Tablets are the generic equivalent of USB Inc'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 USD 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. Aurobindo (incl. Aurolife) now has a total of 193 ANDA approvals (165 Final approvals and 28 Tentative approvals) from USFDA.
Shares of the company declined Rs 16.4, or 1.32%, to settle at Rs 1,225.95. The total volume of shares traded was 160,004 at the BSE (Thursday).