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Reclast

Latest Headlines

Latest Headlines

FDA panel wants bone drugs' labeling changed, but how?

What to do about the potential risks of bisphosphonates? An FDA advisory panel wasn't exactly sure. At a meeting last week, the agency's expert committee voted to change the labeling on these popular

FDA panels to review bone drug safety

Should women using bone-building bisphosphonate drugs take a holiday from therapy to help avoid long-term side effects? Or should they limit use of the popular meds--such as Merck's ($MRK) Fosamax,

Roche keeps up DTC on Boniva while others cut

Marketing osteoporosis drugs has grown more complicated since Merck's Fosamax went off patent a couple years ago. Now that there are low-cost alternatives to branded bisphosphonate treatments,

Bone drugs get new fracture-risk warning

The FDA's review of bone-drug safety turned up enough evidence for a new warning about the risk of a rare-but-serious fracture of the thigh bone. There's been talk about a link between fractures and

Novartis, GSK meds get expanded indications

The FDA has approved Novartis' osteoporosis drug Reclast for an expanded indication. Currently approved as a once-yearly infusion to treat post-menopausal osteoporosis, the drug will now also be

FDA calls 'all clear' on bone meds

Bone drugs Reclast and Fosamax can step out from under a safety cloud, because the FDA came, saw and found nothing. The agency had been reviewing the two meds--sold by Novartis and Merck,

Novartis med gets nod for fracture prevention

SPOTLIGHT: Novartis med gets nod for fracture preventionNovartis said the FDA approved its bone-building drug Reclast as a treatment to prevent additional fractures following a hip fracture; the

FDA: Osteo meds can cause severe pain

Oh, the irony. The very drugs prescribed to strengthen bones can spark stabbing limb and joint pain, according to a reminder from the FDA. Info about the possibility of those pains--which can be

Novartis gains Aclasta, loses Prexige

From the good news, bad news file: Novartis got the EU's approval to sell its new osteoporosis drug Aclasta, known in the U.S. as Reclast. Reclast

ALSO NOTED: FDA to speed up generic approval; Genfit starts Phase II trials; and much more...

Could the steady trickle of generics approvals out of the FDA suddenly become a rapid stream? The agency is touting an initiative, called Generic Initiative for Value and Efficiency (GIVE), to speed