FDA approved boniva's first generic drug for osteoporosis prevention

Source: China Council for the promotion of medicine 2012-03-20 US Food and Drug Administration today approved the first generic drug of boniva (sodium ibandronate) tablet, which can be used to prevent or treat osteoporosis in postmenopausal women only once a month The most common types of bone diseases and osteoporosis are characterized by low bone mass and deterioration of bone tissue structure, resulting in bone fragility and increased risk of hip, spine and wrist fractures Ibandronate is a bisphosphonate drug that helps to increase bone mass and reduce spinal fractures According to the National Institutes of health, more than 400000 people in the United States have osteoporosis or low bone mass at high risk "Osteoporosis is a disease that can be prevented and treated," said Dr Keith Weber, deputy director of the office of drug science at the FDA Center for drug evaluation and research "For people who have to manage their health at any time, it's important to have an affordable treatment plan." FDA approved generic drugs have the same high quality and high efficiency as brand drugs, which provide us with a lower cost alternative The quality standard of generic manufacturing and packaging sites must be the same as that of brand drugs Apotex, orchid health and mylan pharmaceutical have been approved by FDA as manufacturers of 150 mg sodium ibandronate tablets At the same time of distribution of ibandronate, patients and caregivers will be given a drug guidance required by FDA, which describes the risks and adverse reactions that people should pay attention to when using the drug Ibandronate can cause serious side effects, including: esophageal problems, low blood calcium, bone, joint, muscle pain, severe jawbone problems and rare thigh fractures In boniva clinical trials, the most common adverse reactions were back pain, dyspepsia, hand and foot pain, diarrhea, head and muscle pain More information on general ibandronate can be obtained from the manufacturer Original link: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm296488.htm