DAYTON, N.J. — Aurobindo Pharma Ltd. has received approval from the Food and Drug Administration for cetirizine hydrochloride tablets, 5 mg and 10 mg, an over-the-counter allergy medication.
Aurobindo said Tuesday that the FDA has determined the company’s product to be bioequivalent to the reference listed drug, Zyrtec tablets (5 mg and 10 mg) from McNeil-PPC. The FDA’s review of the generic product’s abbreviated new drug application (ANDA) demonstrates that drug is safe and effective for OTC use, as recommended in the submitted labeling, Aurobindo added.
Cetirizine HCl tablets are indicated for the temporary relief of symptoms — including runny nose; sneezing; itchy, watery eyes; and itching of the nose or throat — associated with hayfever or other upper respiratory allergies.
Annual U.S. sales of cetirizine HCl tablets (5 mg and 10 mg) are estimated at about $264 million, according to IRI data reported by Aurobindo.