FDA approves Sunovion’s Aptiom as add-on therapy for epilepsy
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating epileptic seizures, the agency said Friday.
The FDA announced the approval of Aptiom (eslicarbazepine acetate), made by Sunovion Pharmaceuticals, as an add-on medication for seizures in adults. About 200,000 new cases of seizures and epilepsy occur in the United States each year, according to the FDA.
"Some patients with epilepsy do not achieve satisfactory seizure control from existing treatment," FDA Division of Neurology Products acting director Eric Bastings said. "It is important we continue to make new treatment options available to patients."
Eisai introduces Aciphex Sprinkle capsules
WOODCLIFF LAKE, N.J. — Drug maker Eisai has launched a new version of a drug used to treat gastroesophageal reflux disease, the company said Friday.
Eisai announced the availability of Aciphex Sprinkle delayed-release capsules in the 5-mg and 10-mg strengths. The Food and Drug Administration approve the drug in March.
Aciphex Sprinkle capsules, which are approved for use in children aged 1 to 11 for up to 12 weeks, are designed to be broken open and sprinkled on soft food or liquid.
FDA approves generic versions of Aciphex
SILVER SPRING, Md. — The Food and Drug Administration has approved six generic versions of a drug used to treat gastroesophageal reflux disease, or GERD, the agency said Friday.
The FDA announced the approval of the first generic versions of Eisai’s Aciphex (rabeprazole sodium) delayed-release tablets for patients aged 12 and older. The generic products are made by Dr. Reddy’s Labs, Kremers Urban Pharmaceuticals, Lupin Pharmaceuticals, Mylan Pharmaceuticals, Teva Pharmaceuticals USA and Torrent Pharmaceuticals.
"Healthcare professionals and consumers can be assured that FDA-approved generic drugs have met the same rigid standards of quality as the brand-name drug," FDA Office of Generic Drugs acting director Kathleen Uhl said. "This medication is widely used by people who have gastroesophageal reflux disease, so it is important to have access to affordable treatment options."