FDA Approves First Boniva Generic for Osteoporosis

(March 19, 2012) Today, the U.S. Food and Drug Administration (FDA) approved the first generic version of ibandronate (Boniva), a once-a-month pill used to treat or prevent osteoporosis in women after menopause.

 

Osteoporosis is the most common bone disease, characterized by low bone mass and deterioration of bone tissue, leading to increased risk of fracture. Men, as well as women, are affected by osteoporosis.

 

Ibandronate is a bisphosphonate that helps increase bone mass, reducing the risk of fracture. The National Institutes of Health estimates that 40 million men and women have osteoporosis or are at high risk of osteoporosis due to low bone mass.

 

Generic ibandronate will be manufactured by three firms:  Apotex Inc., Orchid Healthcare, and Mylan Pharmaceuticals Inc. They will make ibandronate tablets in 150 milligram strength.  Roche Holding AG, the marketers of Boniva, will continue to sell this drug. It will, however, help out smaller generic companies, as well as offer the public a much more affordable option.

 

Generic drugs which have been approved by the FDA are of the same quality and strength as the brand-name drugs, but they provide a lower cost alternative. The generic manufacturing and packaging must pass the same quality standards as the brand name drugs.

 

The most commonly reported adverse reactions were back pain, indigestion, extremity pain, diarrhea, headache ,and muscle and joint pain. There have been reports of more serious side effects, including esophagus problems, low calcium levels in the blood, severe jaw problems and unusual thigh bone fractures (which is ironic since this drug is advertised as the drug that prevents bone fractures, which we reported to you a few weeks ago). A lower cost for this medication will be appreciated by many patients.

 

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