Regulatory updates for Tris Pharma's Karbinal; GSK's four-strain seasonal flu vaccine

US drug delivery specialist Tris Pharma says that the US Food and Drug Administration has approved its New Drug Application for Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg/5ml, the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial allergic rhinitis in children aged two and over.

"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," said Ketan Mehta, founder, president, and chief executive of Tris Pharma, noting the "the approval of Karbinal ER marks our fourth liquid extended-release NDA approval based upon our proprietary OralXR+ technology. We are in the process of finalizing our marketing partner and plan to launch later this year in anticipation of the fall allergy season."