New drug application for Karbinal ER antihistamine gets OK from FDA

Karbinal ER, an oral suspension antihistamine used to treat patients with allergic rhinitis, received FDA new drug application approval today, according to a company press release.

Tris Pharma’s 4 mg/5 mL H1 receptor antagonist (carbinoxamine maleate) is the first sustained-release liquid antihistamine approved in the US, according to the release. It is indicated for patients aged 2 years and older affected by seasonal and perennial allergic rhinitis.

“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,” Ketan Mehta, president of Tris Pharma, said in the release. “We are in the process of finalizing our marketing partner and plan to launch later this year in anticipation of the fall allergy season.”

Before 2006, carbinoxamine had been readily available in multiple products until the FDA removed all unapproved formulations after a Drug Efficacy Study Implementation review. Only two immediate-release formulas remained, according to the press release, resulting in patients requiring multiple doses daily.