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FDA clears Warner Chilcott osteoporosis drug

Warner Chilcott has won US Food and Drug Administration approval for a new version of its postmenopausal osteoporosis drug Actonel

The Irish pharmaceutical firm Warner Chilcott has won US Food and Drug Administration (FDA) approval for a new version of its Actonel (risedronate sodium) drug, which is a once-weekly treatment for postmenopausal osteoporosis.

The new product will be marketed under the brandname Atelvia and is expected to be launched in early 2011. Unlike Actonel and other drugs in the same class, including Merck's Fosamax (alendronate), Atelvia does not have fasting requirements associated with dosing.

"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 US in this segment," Roger Boissonneault, president and CEO of Warner Chilcott, said in a statement.

In addition, Atelvia gives Warner Chilcott a new lease on its patent protection for the osteoporosis drug. The patent on the old formulation, which has been a major profit driver for the company, expires in 2014, but Atelvia is patent-protected in the US until 2026.

14th October 2010

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