FDA Approvals - Kos Submits Supplemental New Drug Application To FDA For New
Kos Submits Supplemental New Drug Application To FDA For New Niaspan(R) CF Range of Products (Business Wire via Yahoo! Finance)
CRANBURY, N.J.----July 12, 2006--Kos Pharmaceuticals, Inc. : Includes new optimized 1000mg Niaspan CF formulation that has demonstrated an improved overall flushing profile vs. currently commercialized Niaspan, with a 42 percent reduction in severity, and a 43 percent reduction in duration of flushing Niaspan CF launch planned for first quarter 2007 Plans in place to incorporate optimized
Cyberonics Receives FDA Approval for Harmonized/Modularized VNS Therapy System Labeling Format (SYS-CON Media)
Cyberonics, Inc. today announced that it received FDA approval for a harmonized/modularized VNS Therapy(TM) System labeling format and FDA approval to market the VNS Therapy Model 250 Version 7.1.4 Programming Software in the United States.