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FDA approves first generic ibandronate for osteoporosis
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The FDA has approved the first generic versions of the bisphosphonate ibandronate, a once-monthly tablet for the treatment or prevention of osteoporosis in postmenopausal women.
According to the National Institutes of Health, more than 40 million people in the US already have osteoporosis or are at high risk due to low bone mass, the FDA wrote in a press release.
“Men as well as women are affected by osteoporosis, a disease that can be prevented and treated,” Keith Webber, PhD, deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research, said in the press release. “For people who must manage their health conditions over time, it is important to have affordable treatment options.”
Manufacturers who received FDA approval to produce the generic 150 mg tablets are Apotex Inc., Orchid Healthcare and Mylan Pharmaceuticals Inc.
An FDA-required Medication Guide describing the risks and adverse events associated with ibandronate (Boniva, Roche) will be given to patients and caregivers. Serious side effects associated with treatment include: esophagus problems; low calcium levels in the blood; bone, joint or muscle pain; severe jaw bone problems and unusual thigh bone fractures.
In clinical trials for Boniva, the most common adverse reactions were: back pain, dyspepsia, pain in extremity, diarrhea, headache and myalgia.