Zonisade FDA Approval History

Last updated by Judith Stewart, BPharm on July 19, 2022.

FDA Approved: Yes (First approved July 15, 2022)
Brand name: Zonisade
Generic name: zonisamide
Dosage form: Oral Suspension
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Seizures

Zonisade (zonisamide) is an oral suspension formulation of the approved anticonvulsant zonisamide indicated as adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years of age and older.

• Zonisamide was first approved by the U.S. Food and Drug Administration (FDA) in an oral capsule formulation under the brand name Zonegran in 2000. Zonisade is the first FDA approved zonisamide oral liquid formulation, which is useful for patients who have difficulty swallowing or who are unable or unwilling to take the capsules.
• Zonisade is administered once or twice daily with or without food.
• Warnings and precautions associated with Zonisade include potentially fatal reactions to sulfonamides, serious skin reactions, serious hematologic events, drug reaction with eosinophilia and systemic symptoms (DRESS)/multi-organ hypersensitivity, oligohidrosis and hyperthermia in pediatic patients, acute myopia and secondary angle closure glaucoma, suicidal behavior and ideation, metabolic acidosis, seizures on withdrawal of antiepileptic drugs, and teratogenicity.
• Common adverse reactions include somnolence, anorexia, dizziness, ataxia, agitation/irritability, and difficulty with memory and/or concentration.

Development timeline for Zonisade

Further information

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