FDA Approved: LEVETIRACETAM EXTENDED-RELEASE — Original Application (Omnivium Pharmaceuticals LLC)

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Summary

FDA approved an extended-release generic formulation of levetiracetam (ANDA212688) manufactured by Omnivium Pharmaceuticals LLC.

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Diseases / indications

• Epilepsy
• Generalized Tonic-clonic Seizures
• Juvenile Myoclonic Epilepsy
• Partial-onset Seizures

Drugs mentioned

• Levetiracetam Extended-Release (levetiracetam)

Snippet

ORIG AP for LEVETIRACETAM EXTENDED-RELEASE (LEVETIRACETAM)