FDA approves Zyrtec OTC
This article was originally published in The Tan Sheet
Executive Summary
The agency approves Zyrtec (cetirizine HCl) for nonprescription use, one week after it granted McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, approval to switch the allergy treatment's decongestant combination product, Zyrtec-D (1"The Tan Sheet" Nov. 12, 2007, p. 9). The prescription-strength product will be available OTC in stores starting in late January 2008, J&J says in a Nov. 16 release. The firm received approval for Zyrtec in 5 mg and 10 mg tablets, 5 mg and 10 mg chewable tablets and 1 mg/mL syrup. The once-daily drug is indicated for relieving indoor and outdoor allergy symptoms of sneezing, runny nose and watery eyes for up to 24 hours in adults and children; the drug also relieves itching due to hives, J&J says...