Sun Pharma Advanced Research Company Ltd. has said that it has entered into a licensing arrangement for SPARC’s ELEPSIA XRTM (Levetiracetam Extended Release tablets).
As per the agreement, SPARC will license ELEPSIA XRTM (Levetiracetam Extended Release tablets) to a wholly-owned subsidiary of Sun Pharma for the US market. SPARC will receive an up-front payment of USD 10 million from Sun Pharma. It is also eligible for certain additional milestone payments and defined royalties linked to any future sales of ELEPSIA XRTM.
ELEPSIA XRTM was approved by the USFDA in March 2015. However, in September 2015, SPARC received a complete response letter (CRL) from the USFDA rescinding its earlier approval, citing that the compliance status of the manufacturing facility viz., Halol site of Sun Pharma was not acceptable on the date of approval.
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As per the agreement, SPARC will license ELEPSIA XRTM (Levetiracetam Extended Release tablets) to a wholly-owned subsidiary of Sun Pharma for the US market. SPARC will receive an up-front payment of USD 10 million from Sun Pharma. It is also eligible for certain additional milestone payments and defined royalties linked to any future sales of ELEPSIA XRTM. 
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