FDA Approves First Boniva Generics for Osteoporosis

The FDA has approved the first generic versions of Boniva tablets to treat or prevent osteoporosis.

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

"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 high 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.