US OTC Decisions In July: Labeling For Advil Sinus In 2-Count Packages, Lansoprazole, Ibuprofen

Total of approvals for label changes for three OTC products in July equals the number CDER made for nonprescription products in the same month in 2019. July updates include approval of an sNDA for labeling for Advil Sinus Congestion & Pain tablets in packages containing two single-tablet pouches.

Editor's note: HBW Insight’s ongoing feature provides information on decisions during July by the US Food and Drug Administration on new drug applications, including ANDAs, for nonprescription drugs, and on supplemental NDAs about label and package changes for OTC products already available.

The addition of 2-tablet packages of the sinus, congestion and pain formulation of Advil marketed by [See Deal]...