FDA accepts approval application for osteoporis treatment

2/19/2009

THOUSAND OAKS The Food and Drug Administration has accepted a biotech company's submission of an approval application for a monoclonal antibody to treat and prevent postmenopausal osteoporosis and bone loss in patients receiving hormone therapy for prostate or breast cancer.

Amgen announced on Feb. 18 that the FDA had accepted its biologics license application for denosumab, which belongs to the class known as RANK Ligand inhibitors. The company has also applied for approval in Canada, the European Union, Switzerland and Australia. 

The FDA will decide whether to approve the application in October.

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