Noven/Banner Receive FDA “Approvable” Letter For Stavzor
This article was originally published in The Pink Sheet Daily
Executive Summary
Data requested by the agency to complete the 505(b)(2) NDA is all “non-clinical,” Noven says.
You may also be interested in...
Noven's Stavzor Final Approval Anticipated In Mid-2008 After FDA Offers “Tentative Approval”
Valproic acid delayed release capsules gain tentative clearance for manic episodes associated with bipolar disorder and multiple seizures, including epilepsy.
Noven's Stavzor Final Approval Anticipated In Mid-2008 After FDA Offers “Tentative Approval”
Valproic acid delayed release capsules gain tentative clearance for manic episodes associated with bipolar disorder and multiple seizures, including epilepsy.
Noven Gains Phase III Vasomotor Symptoms Candidate With JDS Acquisition
Miami firm predicts four potential new product launches in four years based on specialty pharma JDS’ pipeline.