Teva Agilect "approvable" again
This article was originally published in Pharmaceutical Approvals Monthly
Teva Parkinson's disease treatment Agilect (rasagiline) receives a second "approvable" letter Aug. 4. "There remain a number of issues that Teva believed it had resolved with its submissions, but [where] FDA continues to have concerns," the sponsor states Aug. 5. The firm plans to meet with the agency "promptly" to address the remaining concerns. Teva responded to a July 2004 approvable letter last November, but the review was extended by three months due to a technical error with the NDA...
You may also be interested in...
FDA used an epidemiological approach to resolve concerns regarding a potentially higher risk of melanoma with Teva’s Parkinson’s disease therapy Azilect, review documents show.
3D-printing company Carbon and in vitro diagnostics maker Resolution Medical announced plans to manufacture more than one million 3D-printed nasal swabs per week to test for COVID-19. See what Resolution Medical’s president Shawn Patterson said about it here.
FDA warning to "Genesis II Church of Health and Healing " wasn't its first to the organization about promoting a chlorine dioxide formulation, "Miracle Mineral Solution," as an unapproved new drug. 'Infowars' host Alex Jones also was warned about bogus COVID-19 claims.