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FDA Revokes Approval of Sun Pharma Antiseizure Drug
October 5, 2015.
FDA has revoked its March approval of Sun Pharma’s Elepsia XR antiseizure medication, writes FDA News' Kellen Owings.
The Agency has cited manufacturing quality problems at the Halol, India, facility where Elepsia is produced as the reason for revoking the drug. According to FDA, the compliance status of the Halol facility was not accurately displayed, resulting in the erroneous approval of the NDA.
The revocation is the latest in a series of cGMP issues that have dogged Sun Pharma's Halol facility, including the recall this year of Sun's itbupropion hydrochloride tablets and its eye solutions.
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