Spritam FDA Approval History
Last updated by Judith Stewart, BPharm on July 29, 2025.
FDA Approved: Yes (First approved August 3, 2015)
Brand name: Spritam
Generic name: levetiracetam
Dosage form: Tablets for for Oral Suspension
Company: Aprecia Pharmaceuticals Company
Treatment for: Seizures, Epilepsy
Spritam (levetiracetam) is an antiepileptic used in the treatment of partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures.
- Spritam is indicated for:
- the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg.
- adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.
- adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. - Levetiracetam was first approved under the brand name Keppra in 1999.
- Spritam utilizes the proprietary ZipDose® Technology platform that uses three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid. ZipDose Technology enables the delivery of a high drug load, up to 1000 mg in a single dose.
- Spritam tablets are administered orally twice daily. The tablets are designed to disintegrate in the mouth when taken with a sip of liquid. Spritam may also be administered via nasogastric or gastrostomy feeding tubes.
- Warnings and precautions associated with Spritam include behavioral abnormalities, suicidal behavior and ideation, somnolence and fatigue, serious dermatological reactions, and withdrawal seizures if treatment is stopped suddenly.
- Common adverse reactions (incidence ≥ 5% more than placebo):
- in adults include somnolence, asthenia, infection, and dizziness.
- in pediatric patients include fatigue, aggression, nasal congestion, decreased appetite, and irritability.
Development timeline for Spritam
| Date | Article |
|---|---|
| Jul 22, 2025 | Approval Spritam (levetiracetam) Tablets for Oral Suspension Approved by FDA for Nasogastric and Gastrostomy Tube Administration |
| Aug 3, 2015 | Approval FDA Approves Spritam (levetiracetam) as the First 3D Printed Drug Product |
Further information
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