Spritam

Treats partial-onset seizures. NDA 207958, held by Aprecia Pharms. Levetiracetam.

As of Nov 13, 2026, NDA 207958 (Spritam), held by Aprecia Pharms, was first approved by FDA on Jul 31, 2015, with 9 approved supplements and 0 published complete response letters.

First approved: Jul 31, 2015
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SPRITAM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older weighing more than 20 kg SPRITAM is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy 1.1 Partial-Onset Seizures

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below


Jun 27, 2025	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 19, 2021	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 31, 2015	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

4 strengths and forms


Spritam250MG · tablet, for suspension;oral	Levetiracetam	RxReference drug
Spritam500MG · tablet, for suspension;oral	Levetiracetam	RxReference drug
Spritam750MG · tablet, for suspension;oral	Levetiracetam	DiscontinuedReference drug
Spritam1GM · tablet, for suspension;oral	Levetiracetam	DiscontinuedReference drug

All 10 submissions, including labeling and manufacturing supplements


Jun 27, 2025	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 14, 2024	Supplement 24Labeling · Standard review	Approved	Letter Label Medication Guide
Mar 12, 2024	Supplement 25Labeling · Standard review	Approved	Label Letter
Aug 31, 2023	Supplement 23Labeling · Standard review	Approved	Label Letter
Jan 19, 2021	Supplement 19Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 12, 2018	Supplement 8Labeling · Standard review	Approved	Label Letter
Jun 9, 2017	Supplement 4Labeling · Standard review	Approved	Label Letter
Feb 1, 2016	Supplement 2Labeling · Standard review	Approved	Letter Label
Dec 14, 2015	Supplement 1Manufacturing · Priority review	Approved	None posted
Jul 31, 2015	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 207958
Drugs@FDA: Overview at FDA
Company: Aprecia Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters