Bayer/GSK vardenafil "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA deems Bayer/GlaxoSmithKline's erectile dysfunction drug vardenafil "approvable" July 23, requesting additional short-term clinical pharmacology studies for the phosphodiesterase-5 inhibitor. The approvable decision, coming 10 months after the Sept. 25, 2001 NDA submission, pushes back the projected launch date from second-half 2002 to 2003. The launch of Lilly/ICOS' competing ED therapy, Cialis (tadalafil), also has been delayed - to the second half of 2003. FDA similarly requested pharmacology studies from Lilly/ICOS in an April 29 "approvable" letter (Pharmaceutical Approvals Monthly, May 2002, In Brief
You may also be interested in...
Lilly ICOS Cialis complete response
Lilly ICOS submits a complete response to FDA's April 2002 "approvable" letter for Cialis (tadalafil), the firm announces July 1. The second quarter 2003 submission extends the action date to the fourth quarter of 2003 and contains "clinical pharmacology and other data" requested by FDA. The agency also requested pharmacology studies for Bayer's competing erectile dysfunction therapy, Levitra (vardenafil), which became approvable in July 2002 (1Pharmaceutical Approvals Monthly Aug. 1, 2002, In Brief)...
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.