March 19, 2012 — The US Food and Drug Administration (FDA) today approved the first generic versions of ibandronate (Boniva, Genentech), a once-a-month tablet to treat or prevent osteoporosis in postmenopausal women.
Three companies (Apotex, Orchid Healthcare, and Mylan Pharmaceuticals) received a green light to make generic 150-mg ibandronate tablets.
Ibandronate belongs to the bisphosphonate drug class, which help boost bone mass and reduce the risk for spinal fracture. The National Institutes of Health estimates that more than 40 million men and women have osteoporosis or are at high risk for it because of low bone mass.
"Men as well as women are affected by osteoporosis, a disease that can be prevented and treated," said Keith Webber, PhD, deputy director of the Office of Pharmaceutical Science in the FDA's Center for Drug Evaluation and Research, in an agency press release. "For people who must manage their health conditions over time, it is important to have affordable treatment options."
The FDA approval of generic ibandronate is conditioned on giving patients and caregivers a medication guide that describes the risks and adverse reactions associated with the drug. Potential adverse events include esophagus problems; decreased bloodstream levels of calcium; bone, joint, or muscle pain; severe jaw bone problems; and atypical femur fractures.
In October 2010, the agency required the labels for all bisphosphonates approved for osteoporosis to warn of the possible increased risk for 2 types of atypical femur fractures: subtrochanteric and diaphyseal.
Back pain, indigestion, pain in extremity, diarrhea, headache, and muscle pain were the most commonly observed adverse reactions in clinical trials for Boniva.
Three companies (Apotex, Orchid Healthcare, and Mylan Pharmaceuticals) received a green light to make generic 150-mg ibandronate tablets.
Ibandronate belongs to the bisphosphonate drug class, which help boost bone mass and reduce the risk for spinal fracture. The National Institutes of Health estimates that more than 40 million men and women have osteoporosis or are at high risk for it because of low bone mass.
"Men as well as women are affected by osteoporosis, a disease that can be prevented and treated," said Keith Webber, PhD, deputy director of the Office of Pharmaceutical Science in the FDA's Center for Drug Evaluation and Research, in an agency press release. "For people who must manage their health conditions over time, it is important to have affordable treatment options."
The FDA approval of generic ibandronate is conditioned on giving patients and caregivers a medication guide that describes the risks and adverse reactions associated with the drug. Potential adverse events include esophagus problems; decreased bloodstream levels of calcium; bone, joint, or muscle pain; severe jaw bone problems; and atypical femur fractures.
In October 2010, the agency required the labels for all bisphosphonates approved for osteoporosis to warn of the possible increased risk for 2 types of atypical femur fractures: subtrochanteric and diaphyseal.
Back pain, indigestion, pain in extremity, diarrhea, headache, and muscle pain were the most commonly observed adverse reactions in clinical trials for Boniva.
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