Oct
11
FDA Denies Jazz Pharmaceuticals Approval for Fibromyalgia Drug
Filed Under (Main Content) by Content Keyword RSS
Jazz Pharmaceuticals has been told by the US Food and Drug Administration that its fibromyalgia drug cannot be approved in its present form.
Oct
11
Fibromyalgia New Drug Application JZP-6 (Sodium Oxybate) Turned Down By FDA
Filed Under (Main Content) by Content Keyword RSS
JZP-6 (Sodium Oxybate), a new drug for the treatment of fibromyalgia has been turned down by the Food and Drug Administration (FDA) in a response letter to an NDA (new drug application), saying that in its present form it cannot approve the new compound. The FDA response letter includes several issues, including better patient population data from trials, safety data, and proposed REMS (Risk ...
Oct
11
FDA Wants More Data For Jazz Pharma Fibromyalgia Drug
Filed Under (Main Content) by Content Keyword RSS
FDA Wants More Data For Jazz Pharma Fibromyalgia Drug
Oct
11
FDA says no to Jazz Pharma fibromyalgia drug
Filed Under (Main Content) by Content Keyword RSS
Federal regulators want additional clinical studies of a fibromyalgia drug candidate from Jazz Pharmaceuticals and the failure to get a go-ahead sent company shares down 11 percent before the market opened Monday.
Oct
11
FDA says no to Jazz Pharma fibromyalgia drug
Filed Under (Main Content) by Content Keyword RSS
Federal regulators want additional clinical studies of a fibromyalgia drug candidate from Jazz Pharmaceuticals and the failure to get a go-ahead sent company shares down 11 percent before the market opened Monday.