Aurobindo Pharma receives USFDA Tentative Approval for Lacosamide Tablets

19 Mar 2015 Evaluate

Aurobindo Pharma has received a tentative approval from the US Food & Drug Administration (USFDA) 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 $593 Million for the twelve months ending January 2015 according to I MS.

This ANDA contains a Paragraph IV certification and is currently under litigation in the United States District Court for the District of Delaware [UCB Inc, UCB Pharma GMBH Research Corporation Technologies Inc. and Harris FRC Corporation v. Aurobindo Pharma and Aurobindo Pharma USA Inc, 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 USFDA.

Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s robust product portfolio is spread over 6 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergics, supported by an outstanding R&D set-up.

Aurobindo Pharma Share Price

1217.45 -6.20 (-0.51%)
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