FDA Approves Levetiracetam (ANDA076920)

The U.S. Food and Drug Administration (FDA) has granted approval for application ANDA076920, covering the generic drug Levetiracetam. The product is manufactured by Dr. Reddy's Laboratories Limited and sponsored by Pharmazone. Levetiracetam is marketed as an oral prescription tablet in three strengths: 250 mg, 500 mg, and 750 mg. All three dosage forms are classified as human prescription drugs and are intended for oral administration. The approval process included multiple submissions: an original submission (ORIG) on 2009‑01‑15, labeling supplements on 2009‑07‑31, 2010‑09‑21, and 2012‑04‑26, and a REMS supplement on 2011‑09‑20. Each submission received an approved (AP) status. The product is identified by several NDC codes (e.g., 55111‑181‑30) and is listed under the pharmacologic class of decreased central nervous system disorganized electrical activity. The FDA listing reflects the product type as a human prescription drug. This approval adds a new generic option for clinicians prescribing Levetiracetam for seizure management.