FDA clears Merck & Co's enhanced Fosamax

The US Food and Drug Administration has cleared Merck & Co's modified osteoporosis drug, Fosamax Plus D (alendronate sodium/cholecalciferol), a once-a-week pill which contains 70mg of the already-marketed active ingredient and 2,800 IU (international units) of vitamin D3.

Clinical studies of Fosamax, which first came to market in 1995 and generated sales of $3.2 billion in 2004, have shown that the agent cuts the risk of both hip and spine fractures in postmenopausal women with osteoporosis. Already the most-prescribed product for the condition, it is now the only bisphosphonate with the added benefit of a weekly dose of vitamin D, which is necessary for the development of strong bones, the New Jersey, USA-based drugmaker said.

Commenting on the approval, Robert Heaney, a professor of medicine at Creighton University, Omaha, Nebraska, said: "having a product like Fosamax Plus D available to help physicians better manage vitamin D nutrition in their patients should be welcome news for the estimated 10 million Americans who have osteoporosis and the physicians who treat them."