Spritam FDA Approval History
Last updated by Judith Stewart, BPharm on March 23, 2022.
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.
- 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 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.
- Spritam tablets are administered orally twice daily. The tablets are designed to disintegrate in the mouth when taken with a sip of liquid.
- Spritam is associated with the following warnings and precautions: behavioral abnormalities, suicidal behavior and ideation, somnolence and fatigue, serious dermatological reactions, coordination difficulties, and withdrawal seizures if treatment is stopped suddenly.
- Common adverse reactions in adults and children include somnolence, asthenia, infection, and dizziness. Additional common adverse reactions in children include fatigue, aggression, nasal congestion, decreased appetite, and irritability.
Development timeline for Spritam
| Date | Article |
|---|---|
| Aug 3, 2015 | Approval FDA Approves Spritam (levetiracetam) as the First 3D Printed Drug Product |
Further information
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