FDA approves Karbinal ER (Tris Pharma) for Allergic Rhinitis

The FDA has on 3 April 2013 approved a New Drug Application (NDA) for Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg/5ml, from Tris Pharma, being the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial Allergic Rhinitis in children ages 2 and up.

Prior to 2006, carbinoxamine was widely used, with dozens of carbinoxamine-containing combination products including extended-release solid-dose products. However, nearly all of these were older products that had not gone through the rigorous approval process of the FDA. Following the Drug Efficacy Study Implementation (DESI) review, the FDA removed all unapproved products with the exception of two immediate-release formulations, creating a void for patients and doctors who valued the benefits associated with an extended-release formulation