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FDA Approves Elepsia XR

Sun Pharma Announces FDA Approval of Elepsia XR (levetiracetam) Extended-Release Tablets

March 04, 2015, Mumbai: Sun Pharma Advanced Research Company Ltd. (SPARC) today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Elepsia XR (Levetiracetam extended-release tablets 1000 mg and 1500 mg). Elepsia XR is indicated for adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy.

“Levetiracetam is a very successful and highly effective antiepileptic drug but more than 80% of epilepsy patients require Levetiracetam in does in range of 1000mg to 3000mg resulting in a significant pill burden. Approval of Elepsia XR as 1000mg and 1500mg once a day tablets will be very useful for these patients and physicians.” said Anil Raghavan, Chief Executive Officer of SPARC.

The product will be manufactured by Sun Pharmaceutical Industries Ltd at its Halol (Gujarat) facility in India.

About Elepsia XR

Elepsia XR is a novel extended release formulation of Levetiracetam 1000mg and 1500mg. Elepsia XR has been developed with SPARC’s proprietary Wrap MatrixTM platform technology. Levetiracetam is an antiepileptic drug (AED) indicated for adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy.

About Sun Pharma Advanced Research Company Ltd. (SPARC)

Sun Pharma Advanced Research Company Ltd. (SPARC) is an international pharmaceutical company engaged in research and development of drugs and delivery systems. More information about the company can be found at www.sunpharma.in.

Source: Sun Pharma Advanced Research Company Ltd.

Posted: March 2015

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