Bubblegum-flavored kids’ Zyrtec
This article was originally published in The Tan Sheet
Executive SummaryFDA approves McNeil's proposed label changes and a bubblegum flavor for both Children's Zyrtec formulations, Allergy and Hives Relief (cetirizine 5 mg/5 mL), according to Aug. 14 letters. In addition to the new bubblegum-flavored, sugar-free formulation, the agency approves several manufacturing changes for Children's Zyrtec including the addition of a new manufacturing site for the products, a change in the order of ingredients, adjustment of process temperature and the introduction of a new 2-ounce. bottle size for Children's Zyrtec Allergy syrup. The agency approved Zyrtec for OTC use in November 2007 (1"The Tan Sheet" Nov. 19, 2007, In Brief)
You may also be interested in...
Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.
Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza
The latest drug development news and highlights from our US FDA Performance Tracker.