FDA Rescinds Approval of Sun Pharma’s Elepsia XR

Sun Pharma Advanced Research Co. (SPARC) Sept. 25 announced that the FDA has rescinded its approval for Elepsia XR (levetiracetam extended-release tablets 1000 mg and 1500 mg).

Elepsia XR was approved by the Food and Drug Administration in March for adjunctive therapy in the treatment of partial onset seizures in patients 12 years and older with epilepsy, according to the company’s website.

SPARC said it has received a complete response letter from the FDA rescinding the approval because the compliance status of the manufacturing facility wasn’t acceptable on the date of approval.

Elepsia XR is manufactured at Sun Pharmaceutical Industries ...