Novartis Foresees Aclasta Approval By Year-End Despite Second "Approvable" Letter
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA is seeking additional information from ongoing osteoporosis trials of the zoledronic acid for treatment of Paget's disease.
You may also be interested in...
Novartis Awaits FDA Action On Aclasta After “Approvable” Letter For Paget’s Disease
Novartis is waiting to hear back from FDA on the status of zoledronic acid for the treatment of Paget's disease of the bone after responding to an "approvable" letter from the agency
Bisphosphonate Osteonecrosis May Be Class Effect, FDA Safety Review Says
ODS review finds 139 cases of osteonecrosis in patients receiving IV bisphosphonates Zometa and Aredia, or oral drugs Fosamax and Actonel, although many fewer are found with oral drugs vs. IV. Zometa and Aredia are subject of March 4 oncologic drugs advisory committee meeting on osteonecrosis of the jaw.
‘Shadow’ Factory Challenges Continue For US FDA
Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find disappearing manufacturer of contaminated OTC eye drops.