DAYTON, N.J. — Aurobindo Pharma Limited announced Tuesday that it had received approval from the Food and Drug Administration for its over-the-counter cetirizine hydrochloride in 5- and 10-mg dosage strengths. The drug is a generic version of Zyrtec.
The cetirizine hydrochloride tablets are indicated for temporarily relieves runny nose, sneezing, itchy, watery eyes and itching of the nose or throat caused by hay fever or other upper respiratory allergies.
The product has an estimated market size of $264MM for the twelve months ending January 2014, according to IRI.