Taro Receives Final FDA Approval for Generic Zyrtec Syrup

Taro Pharmaceutical Industries 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 Israeli drugmaker received tentative approval for its generic Zyrtec (cetirizine HCl) ANDA last October and plans to market the product through its U.S. affiliate.

Cetirizine syrup is a prescription medication used to relieve symptoms associated with perennial allergic rhinitis in children age 6–23 months and for hives in children age 6 months to 5 years.

Several firms received 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 owns McNeil.

Perrigo also has received final approval to market its generic Zyrtec syrup.