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ARDEE, Ireland The Food and Drug Administration has approved a new formulation of a drug for osteoporosis made by Warner Chilcott, the drug maker said Monday.
Warner Chilcott announced the approval of Atelvia (risendronate sodium), a treatment for postmenopausal osteoporosis, which it plans to launch early next year. The drug is a delayed-release formulation of Actonel.
“The approval of Atelvia represents an exciting addition to the Actonel franchise, as well as our women’s healthcare product portfolio,” Warner Chilcott president and CEO Roger Boissonneault said. “We believe the dosing convenience of Atelvia sets it apart from other treatment options for osteoporosis patients, and provides an opportunity to regain market share in the United States in this segment.”