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.

OTC Regulatory Decisions Tracker US

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]...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

Pharma Deutschland Seeks To Enter Urban Wastewater Legal Dispute

 
• By 

The Urban Wastewater Treatment Directive “in its current form, is at an end,” insists Pharma Deutschland CEO Jörg Wieczorek. To put the directive to bed once and for all, the association has applied for leave to intervene in the ongoing EU legal battle in its own right.

Cloudy Tariff Conditions Expected To Linger In US

 

White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.

FDA Takes World Tour In Recent OTC Warnings

 

FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By 

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

More from Policy & Regulation

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By 

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

Cloudy Tariff Conditions Expected To Linger In US

 

White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.

Over The Counter: How To Balance Access And Equity In Self-Care, With Bayer’s Emese Csoke

HBW Insight speaks to Bayer Consumer Health's global strategy director for regulatory, medical, safety, quality, and compliance Emese Csoke about how least how widening access to self-care solutions can be balanced with equity with regards to affordability.