Levetiracetam oral

FDA Drug Profile — Levetiracetam

Drug Details

Generic Name
Levetiracetam oral
Brand Names
Levetiracetam
Application Number
ANDA203052
Sponsor
Camber Pharmaceuticals, Inc.
NDC Codes
1
Dosage Forms
SOLUTION
Routes
ORAL
Active Ingredients
LEVETIRACETAM

Indications and Usage

1 INDICATIONS AND USAGE Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam oral solution is indicated for adjunctive therapy for the treatment of: • Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) • Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) 1.1 Partial-Onset Seizures Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam oral solution is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. 1.3 Primary Generalized Tonic-Clonic Seizures Levetiracetam oral solution is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.