FDA sinks Gaviscon "floating" claim
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...
Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.
Delfi Diagnostics will use the new funds to expand its team of cancer researchers and machine-learning experts to validate its novel approach for early cancer detection through multiple prospective clinical trials.
US Ninth Circuit affirms a district court’s summary judgment in favor of Target and manufacturer of Up & Up brand biotin supplement it sells. Indian manufacturer targeted in putative class-action in New York prompted FDA’s 2016 creation of import alert category for Ayurvedic supplements.