FDA Approves Generic Levetiracetam Tablets (ANDA078993)

The U.S. Food and Drug Administration announced approval of labeling for generic levetiracetam tablets under application number ANDA078993. The approved products are oral tablets available in four strengths—250 mg, 500 mg, 750 mg, and 1 g—and are designated as prescription drugs. Manufacturers listed for these products are BluePoint Laboratories and Aurobindo Pharma Limited. The approvals were issued through standard review, with labeling submissions numbered 17, 19, 33, and 35, and approval dates of January 24 2024 and February 5 2025. These tablets are classified as human prescription drugs and are intended to provide a generic alternative to the branded levetiracetam product.