FDA Approves First Generic Version of Boniva to Treat Osteoporosis

Posted on March 22, 2012

The FDA has announced approval of the first generic version of Boniva (ibandronate) tablets. Apotex Inc., Orchid Healthcare, and Mylan Pharmaceuticals Inc. have gained FDA approval to make generic 150 milligram ibandronate tablets.

The once a month pill is used to treat or prevent osteoporosis in women after menopause. Osteoporosis is characterized by low bone mass and structural deterioration of bone tissue. It leads to bone fragility and an increased risk of fractures of the hip, spine, and wrist. The National Institutes of Health estimates that 40 million people have osteoporosis or are at high risk for it.

Keith Webber, Ph.D., deputy director of the Office of Pharmaceutical Science in the FDA's Center for Drug Evaluation and Research, says, "Men as well as women are affected by osteoporosis, a disease that can be prevented and treated. For people who must manage their health conditions over time, it is important to have affordable treatment options."

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