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FDA Approves Liquid Form of Zonisamide
Zonisade is the first oral liquid form of zonisamide to be approved by the FDA to treat patients with epilepsy.
The FDA has approved Azurity Pharmaceuticals’ Zonisade (zonisamide), an oral suspension formulation to treat partial seizures in adults and pediatric patients aged 16 years and older with epilepsy.
James W. Wheless, M.D.
“The provider community continues to seek reliable formulations of medicines that may reduce the epilepsy patient and caregiver burden and help improve treatment adherence,” James W. Wheless, M.D., chair, Pediatric Neurology, University of Tennessee Health Science Center in Memphis, said in a press release. “Zonisade addresses an important unmet need in patients who have difficulty swallowing or who are unable or unwilling to take tablets.”
Zonisade was developed by Eton Pharmaceuticals, and was one of three drugs sold to Azurity in February 2021. The other two therapies include lamotrigine and topiramate. Topiramate was approved by the FDA in November 2021 with the brand name of Eprontia.
Related: FDA Approves Liquid Formulation of Seizure Medication
An estimated 65 million people have epilepsy globally, and 1 in 26 people will develop epilepsy in the United States. Zonisamide is available as a generic in a capsule form from several manufacturers.
FDA Approves Pfizer’s Gene Therapy for Beqvez for Hemophilia
April 26th 2024Beqvez (fidanacogene elaparvovec) is priced at $3.5 million, which is on parity with Hemgenix, the first one-time therapy to treat adults with hemophilia B. Pfizer’s warranty will refund insurers and continue to provide coverage for patients if they change insurers.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
