First Boniva Generics for Osteoporosis Have FDA Approval

The first generic versions of Boniva (ibandronate) tablets, a once-monthly product for managing or preventing osteoporosis in postmenopausal women, have received FDA approval. For persons who must manage their health conditions over time, having affordable treatment options is important, the FDA noted.

FDA-approved generic drugs have the same high quality and strength as brand-name drugs and provide a lower-cost alternative, the agency noted, and the generic manufacturing and packaging sites must pass the same quality standards. An FDA-required Medication Guide that will be given to patients and caregivers when ibandronate is dispensed describes the risks and adverse reactions patients should be aware of when using the drug.

The manufacturers that have gained FDA approval to make generic 150-mg ibandronate tablets are Apotex Inc, Orchid Healthcare, and Mylan Pharmaceuticals Inc. Information about the availability of generic ibandronate can be obtained from them. More than 40 million persons in the United States already have osteoporosis or are at high risk for the condition because they have low bone mass, according to the NIH.