Perrigo Gets Final Nod for Generic Zyrtec Syrup

Perrigo has received final FDA approval to manufacture and market a generic version of McNeil Consumer Healthcare’s prescription Zyrtec syrup 1 mg/mL to treat symptoms of seasonal allergic rhinitis. 

The product will join the company’s line of cetirizine tablets, cetirizine D and cetirizine OTC syrup, Joseph Papa, Perrigo’s chairman and CEO, said. Teva also sells a generic version of Zyrtec (cetirizine HCl) syrup.

Perrigo was one of several firms to receive FDA approval late last year for generic versions of Zyrtec tablets approved for OTC use. Pfizer stopped marketing Zyrtec in January after selling the rights to the nonprescription version of the drug in 2006 to Johnson & Johnson, which includes McNeil in its family of companies.

Actavis, Apotex, Caraco Pharmaceutical Laboratories, Mylan, Par Pharmaceutical, Perrigo, Ranbaxy Laboratories, Sandoz and Wockhardt have received final approval to market the generic 5- and 10-mg tablets for treating allergies and hives, according to the FDA Orange Book.

Zyrtec and Zyrtec D had sales of roughly $1.5 billion last year, down 2 percent from the previous year, according to Pfizer.