MONMOUTH JUNCTION, N.J. — The Food and Drug Administration has approved a new drug for allergies in children made by Tris Pharma, the drug maker said Wednesday.
Tris announced the approval of Karbinal ER (carbinoxamine maleate) extended-release oral suspension in the 4 mg-per-five milliliter strength. The company said the drug was the first sustained-release histamine receptor blocking agent for seasonal and perennial allergic rhinitis in children 2 and older.
"Karbinal ER is dosed only once every 12 hours, making it an attractive treatment option for the millions of allergy sufferers who don't respond to second-generation antihistamines and aren't satisfied with the cumbersome dosing schedules associated with the first-generation antihistamines," Tris Pharma president and CEO Ketan Mehta said. "The approval of Karbinal ER marks our fourth liquid extended-release NDA approval based on our proprietary OralXR+ technology."