Blistex
Executive Summary
Plans to submit clinical evidence demonstrating the efficacy of allantoin and dimethicone for fever blister/cold sore treatment, the company told FDA in a May 25 letter. Blistex is seeking inclusion of the ingredients as Category I for treatment of fever blisters and cold sores in the TFM for OTC skin protectants. Allantoin and dimethicone are listed as Category I skin protectants in the TFM, which was published in the Jan. 31 Federal Register ("The Pink Sheet" Feb. 5, p. 19). New data must be submitted by Jan. 21, 1991.
You may also be interested in...
FDA To Ramp Up ASCA Pilot In 2021
A report from the US FDA says the agency will focus on updating its premarket submission portal, training staff and taking additional steps to start taking in applications for ASCA pilot participant sponsors.
Scotland's MGB Plots Phase III For Promising Antibacterial
With a late-stage compound on its hands, MGB is currently in discussions with several biotech and pharma companies and also with venture capitalists to continue late-stage development of a novel antibiotic which could transform treatment of Clostridium difficile.
AstraZeneca Vaccine May Only Gain EU Approval In Under 70s
AZ and the EU are at loggerheads over supplies of the COVID-19 vaccine. On top of that, its marketing authorization will present dilemmas.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: