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Novartis wins approval letter from FDA for Aclasta to treat Paget's disease |
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Thursday, 23 February 2006 |
ZURICH (AFX) - Novartis AG last Friday said it has received an approvable letter from the US Food and Drug Administration for zoledronic acid, known under the trade name of Aclasta, which is under review for the treatment of Paget's disease of the bone.
ZURICH (AFX) - Novartis AG last Friday said it has received an approvable letter from the US Food and Drug Administration for zoledronic acid, known under the trade name of Aclasta, which is under review for the treatment of Paget's disease of the bone.
The letter means the FDA is prepared to approve the drug if certain conditions are met.
Novartis said it is confident that providing the additional information will help it obtain final approval by the end of 2006. It added that it still expects clearance in the US and EU for the treatment of osteoporosis in 2007.
It said this is the second approvable letter received for zoledronic acid for this indication, and the FDA has now requested additional data from its ongoing clinical trial program for osteoporosis.
Paget's disease is a chronic and sometimes painful disorder affecting more than one mln people in the US. |
