Thursday 19 March 2015

Aurobindo Pharma receives USFDA tentative approval for Lacosamide, stock trade higher

Aurobindo (incl. Aurolife) now has a total of 193 ANDA approvals (165 Final approvals and 28 Tentative approvals) from USFDA.

Aurobindo Pharma Limited 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 US$ 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 Inc, UCB Pharma GMBH Research Corporation Technologies Inc. and Harris FRC Corporation v. Aurobindo Pharma Ltd. and Aurobindo Pharma USA Inc, Civil Action No. 1:13-cv-01210-UNA].

Aurobindo (incl. Aurolife) now has a total of 193 ANDA approvals (165 Final approvals and 28 Tentative approvals) from USFDA.

At 2:28 PM, the stock were trading higher 2.3% at Rs.1,272. The stock has hit a high of Rs. 1,279 and a low of Rs.1,250.

Total traded quantity on the counter stood at over 1.05 lk shares on BSE.

Meanwhile, the benchmark BSE Sensex is trading at 28,707 up 85 points

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