FDA nod for Aurobindo's OTC cetirizine solution
This article was originally published in Scrip
Executive Summary
Aurobindo Pharma has received final US FDA approval for cetirizine hydrochloride solution 1mg/mL (OTC), a generic version of McNeil Consumer Healthcare Children's Zyrtec oral solution 1 mg/mL and children's Zyrtec oral solution 1 mg/mL. The product is used for the relief of symptoms associated with seasonal allergic rhinitis in adults and children over two years of age, and certain other indications including relief from itching due to hives. Aurobindo expects to launch the product shortly. The company has a total of 83 ANDA approvals and 28 tentative approvals from the FDA.