Shares of Sun pharma and its research arm SPARC fell in the morning trade 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 the morning trade on Monday after the US Food and Drug Administration (USFDA) revoked an approval issued in March to SPARC for an epilepsy drug.
At 11.34 am, the SPARC shares were trading 2.32 per cent down at Rs 376.95 apiece. The scrip opened at Rs 379 and had touched a high and low of Rs 379 and Rs 368.50, respectively, in trade so far.
Sun Pharma shares were down 2.42 per cent at Rs 869 apiece. Sensex was down 54.50 points, or 0.21 per cent, at 25,809.
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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