MONMOUTH JUNCTION, N.J. — The Food and Drug Administration has accepted a regulatory approval application from Tris Pharma for a drug to treat allergies in children ages 2 years and older, Tris said Wednesday.
Tris said that if approved, its carbinoxamine extended-release oral suspension would provide an alternative to currently available immediate-release formulations.
Carbinoxamine is a mildly sedating antihistamine. Before 2006, it was widely used, with more than 100 products containing the drug, but nearly all were older drugs that hadn’t undergone the FDA’s approval process. The agency removed all of them except two immediate-release formulations.