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- zonisamide oral suspension (ET-104) / Eton Pharma, Azurity Pharma
Trial completion date, Trial initiation date, Trial primary completion date: Study of the Pharmacokinetics, Safety, and Tolerability of ZONISADE in Children 1 Month to 17 Years of Age With Partial-onset Seizures (clinicaltrials.gov) - Dec 12, 2024
P4, N=40, Not yet recruiting, Sponsor: Azurity Pharmaceuticals
Trial completion date: Jun 2025 --> Mar 2026 | Initiation date: Sep 2024 --> Feb 2025 | Trial primary completion date: Jun 2025 --> Mar 2026
- | zonisamide oral suspension (ET-104) / Eton Pharma, Azurity Pharma
New P4 trial: Study of the Pharmacokinetics, Safety, and Tolerability of ZONISADE in Children 1 Month to 17 Years of Age With Partial-onset Seizures (clinicaltrials.gov) - Aug 2, 2024
P4, N=40, Not yet recruiting, Sponsor: Azurity Pharmaceuticals
- || zonisamide oral suspension (ET-104) / Eton Pharma, Azurity Pharma
Review, Journal: Bioequivalence of Different Formulations of Zonisamide Oral Suspensions: A Short Review. (Pubmed Central) - Nov 13, 2023
As a narrow therapeutic window drug, zonisamide requires precision in dosing, which could be achieved only with dosage forms with established bioavailability, efficacy, and safety. In order to avoid underdosing and toxicity with zonisamide oral suspensions and utilize their full therapeutic potential, it is necessary to perform bioequivalence studies with each variation of extemporaneously compounded oral suspension and also clinical trials with both commercial and extemporaneous oral suspensions of zonisamide.
- ||| zonisamide / Generic mfg., zonisamide oral suspension (ET-104) / Eton Pharma, Azurity Pharma
FDA event: $ETON Eton Pharmaceuticals Announces FDA Approval of ZONISADE™ (Zonisamide Oral Suspension) https://t.co/8w3FA8JiMA #fdaapproval (Twitter) - Jul 18, 2022
- || zonisamide oral suspension (ET-104) / Eton Pharma
NDA, PDUFA date: $ETON FDA Accepts NDA for Zonisamide Oral Suspension. PDUFA 05/29/21 (Twitter) - Oct 15, 2020