Sun Pharma Advanced Research Company Ltd. Receives Complete Response Letter for Elepsia XR
Mumbai, September 25, 2015 -- Sun Pharma Advanced Research Company Ltd. (SPARC) (Reuters: SPRC.BO, Bloomberg: SPADV IN, NSE: SPARC, BSE: 532872) today announced that the U.S. Food and Drug Administration (USFDA) has issued a Complete Response letter (CRL) to its New Drug Application (NDA) for Elepsia XR (Levetiracetam extended-release tablets 1000 mg and 1500 mg). SPARC had earlier received a final approval from USFDA in March 2015 for this product and was evaluating several marketing partners for commercialization. However SPARC has now received a CRL from the USFDA rescinding its earlier approval, citing that the compliance status of the manufacturing facility was not acceptable on the date of approval.
Elepsia XR is to be manufactured at Sun Pharmaceutical Industries Ltd (SPIL)’s Halol facility. SPIL is working with USFDA in resolving the cGMP deviations at the facility and has taken several corrective measures.
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.
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: September 2015
- Sun Pharma Announces FDA Approval of Elepsia XR (levetiracetam) Extended-Release Tablets - March 4, 2015
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