Novartis Foresees Aclasta Approval By Year-End Despite Second "Approvable" Letter
This article was originally published in The Pink Sheet Daily
FDA is seeking additional information from ongoing osteoporosis trials of the zoledronic acid for treatment of Paget's disease.
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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
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.
A fresh executive order from US president Joe Biden calls for short-term and long-term study, broad consultation, and co-ordination with allies on the domestic supply chain.