FDA Approves Generic Boniva
On March 19, 2012, the FDA approved the first generic versions of Boniva® (ibandronate), an oral bisphosphonate taken once-monthly to prevent or treat bone loss from osteoporosis, helping to reduce the risk of spinal fracture. The generic drug will be produced in 150-mg tablets by Apotex Inc, Orchid Healthcare, and Mylan Phamaceuticals Inc, and will be packaged with a guide outlining the potential serious side effects from ibandronate use, including esophageal problems, muscle pain, low blood-calcium levels, and, more rarely, femoral fractures. In clinical trials for Boniva, the most common adverse reactions were back pain, indigestion, pain in the extremities, diarrhea, headache, and muscle pain.
According to the National Institutes of Health, more than 40 million people in the United States have osteoporosis or are at high risk for it. Boniva is commonly used in postmenopausal women but has also been prescribed to men. “Men as well as women are affected by osteoporosis, a disease that can be prevented and treated. For people who must manager their health conditions over time, it is important to have affordable treatment options,” said Keith Webber, PhD, deputy director, Office of Pharmaceutical Science, FDA Center for Drug Evaluation and Research, in an FDA press release.
