Sinclair Pharma's Gum Disease Mouthwash Gains 510(k) Clearance
This article was originally published in The Pink Sheet Daily
The company has not yet identified a marketing partner for the prescription-use oral rinse Decapinol. The product was vetted by FDA's Office of Combination Products and is considered a device because "its primary mode of action is to create a physical barrier," preventing bacteria from clinging to tooth surfaces, agency says.
You may also be interested in...
The federal government is on the verge of ensuring that 90% of Medicare-eligible people receive prescription drug coverage, HHS Secretary Leavitt said.
HHS Office of Inspector General will decide whether GlaxoSmithKline can donate medicines to Part D-enrolled patients.
BioScrip will be the only provider of Medicare Part B-covered drugs through the competitive acquisition program for three years.