FDA Yanks Approval of Sun Pharma Antiseizure Medication

The FDA has revoked its March approval of Sun Pharma’s Elepsia XR antiseizure medication, citing manufacturing quality problems at the Halol, India, facility where the drug is produced.

The approval occurred while CDER was transitioning to a new application review system and the compliance status of the Halol facility was not accurately displayed, resulting in the erroneous approval of the NDA, FDA spokesman Christopher Kelly said.

The move is a setback for Sun Pharma Advanced Research Company, the Indian drugmaker’s research arm. Elepsia XR (levetiracitam extended-release) was the firm’s first drug to receive FDA approval, and the company was in the process of evaluating potential marketing partners.

Sun’s Halol facility has been plagued by cGMP issues in recent years, resulting in multiple recalls. In July, the drugmaker recalled bupropion hydrochloride tablets and in March, eye solutions made at the site. Those actions followed 2014 recalls by the Halol facility and Detroit-based Caraco Pharmaceutical Laboratories, which distributes drugs for Sun in the U.S.

The company also is recalling two drugs manufactured by its Mutual Pharmaceutical subsidiary. — Kellen Owings