FDA sinks Gaviscon "floating" claim
Executive Summary
Marion's petition to amend the final monograph for OTC antacid drug products to include the ingredient alginic acid and the labeling claim "floating" denied by FDA. Agency said its advisory review panel recognized that alginic acid-containing products may produce a layer of material floating on top of the contents of the stomach but concluded that there was insufficient evidence to support the claim that such a property contributes to the product's effectiveness. Gaviscon, which was approved via NDA, includes alginic acid as an inactive ingredient.
You may also be interested in...
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.