SPARC, Sun Pharma shares fall as USFDA revokes approval for epilepsy drug

By: | Updated: September 28, 2015 4:10 PM

Shares of Sun pharma and its research arm Sun Pharma Advanced Research Company (SPARC) fell in on Monday after the US Food and Drug Administration (USFDA) revoked an approval issued in March to SPARC for an epilepsy drug.

Sun Pharma SPARCShares of Sun pharma and its research arm SPARC fell on Monday after the USFDA revoked an approval issued in March to SPARC for an epilepsy drug. (Reuters)

Shares of Sun pharma and its research arm Sun Pharma Advanced Research Company (SPARC) fell in on Monday after the US Food and Drug Administration (USFDA) revoked an approval issued in March to SPARC for an epilepsy drug.

SPARC closed 2.62 per cent down at Rs 375.80 on BSE while Sun Pharma closed 3.42 per cent down at Rs 860.80.

SPARC has received Complete Response letter (CRL) form USFDA for 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 commercialisation.

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.

In a BSE filing SPARC said, “Elepsia XR TM is to be manufactured at Sun Pharmaceutical Industries (SPIL)’s Halol facility. SPIL is working with USFDA in resolving the cGMP deviations at the facility and has taken several corrective measures.”

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