Tris Pharma announced that the FDA has approved its New Drug Application (NDA) for Karbinal ER (carbinoxamine maleate) Extended-Release Oral Suspension for the treatment of seasonal and perennial allergic rhinitis in children >2 years old. Karbinal is a histamine-H1 receptor blocker with anticholinergic and mild sedative properties.
Prior to 2006, carbinoxamine was widely used with numerous carbinoxamine-containing combination products. However, most of these older products had not gone through the FDA’s approval process. Following the DESI review, the FDA removed all unapproved products with the exception of two immediate-release formulations. Karbinal ER is the first extended-release liquid antihistamine to be approved.
Karbinal ER will be available in a 4mg/5mL strength oral suspension. It is expected to launch in the fall of 2013.
For more information call (732) 940-0358 or visit www.karibinal.com.