Novartis announced on February 24 that it has received the approval letter from the US FDA for for zoledronic acid (5mg infusion), which is under review for the treatment of Paget's disease of the bone.
Paget’s disease of the bone is a condition that alters the normal process of bone remodeling. While normally bones are breaking down and rebuilding throughout a person’s life, once affected with Paget’s, the bones can break and bend more easily and when they re-grow, the bones are soft and porous resulting to shortening in the affected parts of the body. Paget’s disease is a chronic and painful disorder affecting more that 1 million people in the US.
Novartis is confident that providing this additional information to the FDA will help obtain final approval by the end of 2006 and allow this important therapy to be offered to patients living with Paget's disease. Submission for osteoporosis in the
and EU remains planned for 2007. Zoledronic acid 5 mg, under the trade name Aclasta®, has been approved in 41 countries worldwide, including the EU, for the treatment of Paget's disease.
Read more at PharmaLive or you can download the original press release (a pdf file).
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