US Food and Drugs Administration has withdrawn an approval granted in March to Sun Pharma Advanced Research Company’s (SPARC) anti-epileptic drug due to regulatory compliance issues at Sun Pharma's Halol plant.
SPARC, which earlier in the week filed letter of offer with Sebi to raise Rs 250 crore through rights issue, had received FDA approval for its Elepsia XR tablets (Levetiracetam) in March.
Analysts estimated modest sales of about $50 million annually from Elepsia XR which is to be manufactured at Sun Pharma's Halol plant.
“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 complete response letter from the USFDA rescinding its earlier approval, citing that the compliance status of the manufacturing facility was not acceptable on the date of approval,” company said in a statement. It added that Sun Pharmaceuticals is working with USFDA in resolving good manufacturing practices deviations at the facility and has taken corrective measures.
Analysts see this development has a negative for Sun Pharmaceuticals and see two implications – continued disruptions in maintaining supply commitments and impact of key pipeline approval for Sun Pharmaceuticals.
US FDA had made adverse observations in their audit of Halol plant last year and the company's sales last fiscal were impacted due to it. Elepsia XR is a novel extended release formulation of Levetiracetam tablets. Levetiracetam is an anti-epileptic drug indicated for adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy.