Mifepristone
Executive Summary
Second "approvable" letter for abortifacient (RU-486) sent to the Population Council Feb. 18. The drug was first deemed "approvable" on Sept. 18, 1996, pending resolution of manufacturing issues. The Population Council's licensee for mifepristone, Danco Laboratories, said it "is currently preparing information to satisfy the FDA's request." A timely response by Danco would allow FDA to clear the drug ahead of the Presidential nominating conventions this summer
You may also be interested in...
FDA Allocates $13.5 Mil. For Inspection Requirements In FY 2001 Budget
FDA wants to allocate $13.5 mil. in the FY 2001 budget request to come closer to its statutory obligations to conduct inspections. The requirements call for biennial inspections of most FDA-regulated facilities.
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011