Perrigo, Sandoz get Zyrtec-D generic approval
This article was originally published in The Tan Sheet
Executive Summary
Allegan, Mich.-based Perrigo's development partner, Teva Pharmaceutical Industries, along with Novartis subsidiary Sandoz separately received final FDA approval for Abbreviated New Drug Applications for private-label versions of McNeil Consumer Healthcare's Zyrtec-D extended-release tablets, according to FDA. The OTC cetirizine 5 mg/pseudoephedrine 120 mg extended-release tablets carry an indication for 12-hour relief of indoor and outdoor allergy symptoms and nasal congestion, Perrigo says in a March 6 release. FDA approved Zyrtec and Zyrtec-D for OTC use in November, and Perrigo wasted no time in launching its Zyrtec equivalent in January, ahead of the branded product (1"The Tan Sheet" Nov. 19, 2007, In Brief and 2"The Tan Sheet" Feb. 11, 2008, p. 9). The firm says it anticipates shipping the product in the next 90 days...