Kos Gets GMP Warning Letter On Niaspan, Advicor Production
This article was originally published in The Pink Sheet Daily
Executive Summary
The quality control unit failed to investigate dissolution and content uniformity failures for the lipid-altering products, FDA says. The company was cited for similar violations in 2002.
You may also be interested in...
Barr To Co-Promote Kos' Anti-Cholesterol Products Under Settlement
Barr's patent litigation settlement with Kos includes a co-promotion agreement for the brand firm's cholesterol-lowering products Niaspan and Advicor
Pink Sheet Podcast: Relyvrio And Public Promises, Allergy Biomarker Adcomms, PMDA In The USA
Pink Sheet reporters and editor discuss the implications of Amylyx following through on its pledge to remove Relyvrio from the market after its trial failed, an FDA idea to bring potential biomarkers for promising allergy and asthma treatments to advisory committees, and Japan’s PMDA opening an office in Washington D.C.