USFDA denies approval to SPARC’s epilepsy drug

In a presentation this June, SPARC had said that the market for the drug in the USA is at 720 million units and is growing at 5 year compounded annual growth rate (CAGR) of 9 per cent. It had forecast that opportunity exists to market Elepsia XR at significant premium to generics.

The Food and Drug Administration (FDA) has withdrawn their approval of a New Drug Application (NDA) for Elepsia XR (levetiracetam; Sun Pharma) extended-release tablets due to regulatory issues at the manufacturing plant. 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.

On NSE, shares of the company fell 2.97 per cent to Rs 375.35.

The company earlier received the final approval from the USFDA in the month of March in 2015 for this particular product – hence they have been evaluating many marketing partners for the commercialization of this product.

Unfortunately, the CRL comes at a time when Sun Pharma has come under fire for numerous quality-control and compliance issues, including adverse observations made during a plant audit in Halol previous year.

Jimeet Modi, chief executive of Samco Securities said that the concerns on the revocation of the approval pertains to Sun Pharma’s Halol facility have been significantly factored in the price correction. The upshot of this are continued disruptions in maintaining supply commitments, as well as increasing lack of trust in Sun Pharma and their products.

SPARC said Sun Pharma is working with USFDA in resolving the cGMP deviations at the facility and has taken several corrective measures. Elepsia XR TM is to be manufactured at Sun Pharmaceutical Industries Ltd (SPIL)’s Halol facility.