Generic drug makers announce FDA approval for Zyrtec

ALLEGAN, Mich. Like Claritin before it, Zyrtec will be faced with private-label competition not too long after reaching store shelves. Mylan, Perrigo and Caraco Pharmaceutical on Friday separately announced that they have received final approval from the Food and Drug Administration for their abbreviated new drug application, for over-the-counter cetirizine, 5 mg and 10 mg.

The products will be comparable to McNeil Consumer Healthcare’s Zyrtec, indicated for allergy and hives relief, which is expected to reach store shelves Jan. 24.

According to Wolters Kluwer data provided by Perrigo, brand sales for the original prescription strength version of the product for the 12 months ending October 2007 were approximately $1.4 billion.

Brand sales for comparable Claritin and Claritin D were a combined $285.9 million for the 52 weeks ending Oct. 7 across food, drug and mass (excluding Wal-Mart) channels, according to Information Resources, Inc.