FDA approves request after Nexium 24HR marketer Haleon responded March to changes-being-effected letter asking for label change to the delayed-release PPI.
Nexium 24HR is the second OTC proton pump inhibitor available in the US to add a label warning about a potential risk of rare skin reaction, a change firms marketing generic equivalents also are expected to make.
The FDA Center for Drug Evaluation and Research
The US Food and Drug Administration has released a roadmap to adopt new approach methodologies in lieu of animal testing for monoclonal antibody therapies and other drugs, which may include OTC drugs though the proposal does not specifically include cosmetics.
An application for melatonin as an OTC medicine is on the agenda for the next German switch committee meeting, despite the hormone being widely available in food supplements. Acyclovir as a buccal tablet and second-generation antihistamine rupatadine are also up for discussion.
Dyes and colors which FDA says industries agree should no longer be used aren’t unsafe and are currently used only with the agency’s approval, industry stakeholders say. Center for Science in the Public Interest says the dyes are used “in tens of thousands of foods and beverages that are commonly consumed here in the United States.”
