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FDA approves first Boniva generics

Generic osteoporosis treatment: The most commtype bone disease is osteoporosis. The U.S. Food Drug Administratirecently approved first generic versions Boniv(ibandronate)

Generic osteoporosis treatment: The most common type of bone disease is osteoporosis. The U.S. Food and Drug Administration recently approved the first generic versions of Boniva (ibandronate) tablets for the treatment and prevention of osteoporosis in women after menopause. | FILE PHOTO

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Updated: March 20, 2012 11:22AM



The U.S. Food and Drug Administration approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause.

The most common type of bone disease, osteoporosis, is characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased risk of fractures of the hip, spine, and wrist. Ibandronate is in a class of medications called bisphosphonates that help increase bone mass and reduce the chance of having a spinal fracture.

According to the National Institutes of Health, in the United States more than 40 million people either already have osteoporosis or are at high risk due to low bone mass.

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

Generic drugs approved by FDA have the same quality and strength as brand-name drugs and provide a lower cost alternative. The generic manufacturing and packaging sites must pass the same quality standards as those of brand name drugs.

Apotex Inc., Orchid Healthcare, and Mylan Pharmaceuticals Inc. are the manufacturers that have gained FDA approval to make generic 150 milligram ibandronate tablets.

Information about the availability of generic ibandronate can be obtained from the manufacturers.

To learn more:

FDA: Understanding Generic Drugs

National Institutes of Health: Osteoporosis



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