FDA says Aclasta "approvable" for Paget's
Switzerland's Novartis says it received an FDA "approvable" letter for Aclasta to treat Paget's disease of the bone. The FDA has requested additional data from an ongoing trial of the drug for osteoporosis. Novartis added that it believes it can win final approval this year. Novartis is pursuing EU and FDA approval for Aclasta as a therapy for osteoporosis in 2007.
- here's the report from AFX
PLUS: Novartis is investing $83 million in a manufacturing and R&D center in China's Jiangsu Province. Report


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