Biphosphonate class drug Boniva also sold worldwide under the brand names Bonviva and Bondronat is now available for sale in the United States. The Food and Drug Administration has approved it’s use – prescription by doctors and distribution in pharmacies for sale in the prevention and treatment of osteoporosis in post-menopausal women. (1) The primary chemical compound in Boniva is ibandronate sodium. The drug is not prescribed for men unless they are participating in clinical trials.
The drug approved by FDA is the generic version of Boniva which are essentially tablets of ibandronate. This makes the drug more affordable through cheaper pricing. According to Keith Webber, Ph.D., deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research, “Men as well as women are affected by osteoporosis, a disease that can be prevented and treated. For people who must manage their health conditions over time, it is important to have affordable treatment options.” (2)
The generic version of the Boniva will have the same good quality, strength and safety as the branded version as they will have passed through the same set of quality standards’ test as the branded version before being distributed, but will provide a lower cost option for patients.
The manufacturer of branded Boniva, Roche Laboratories, already sells the drug under brand name Bonviva through distributors Nycomed in key Asia-Pacific markets such as China, Hong Kong, Malaysia, Australia, New Zealand, Philippines, Singapore, Taiwan and Vietnam. Roche brand Bondronat also sells in the European, Asian and Australian markets.
In the US, 3 manufacturers have obtained the nod from FDA for the production of the 150 milligrams of ibandronate or generic Boniva – . They are Apotex Inc., Orchid Healthcare, and Mylan Pharmaceuticals Inc.
Boniva helps increase bone mass in elderly women suspected of starting the symptoms of osteoporosis or obtaining low scores on bone mass tests as well as those who have had a diagnosis of osteoporosis. This tablet is taken once a month and under doctor’s supervision. Boniva is also said to aid in the reduction of incidences of spinal fractures. The optimum duration of the treatment has not yet been established and for this reason the treatment program for a patient should be regularly assessed. (3)
Branded or generic, ibandronate and it’s equivalent ibandronic acid come with a host of caveats to the consumer. An FDA-required Medication Guide will be given to patients as well as caretakers that will clearly chalk out the risks and possible adverse side effects the drug can bring in some patients. Ibandronate may cause acute negative side effects such as problems of the esophagus, pain in the muscles, bones and joints, jaw bone deterioration, thigh bone fractures etc. However, these problems are not very common. The more usual and commonly reported side-effects of ibandronate are heartburn, diarrhoea, headache and flu-like symptoms. (4)
- UPDATE 2-FDA approves generic Boniva for osteoporosis; Reuters News, U.S; march 2012; http://www.reuters.com/article/2012/03/19/boniva-idUSL1E8EJCKR20120319
- FDA approves first Boniva generics to treat or prevent osteoporosis; US Department of Health & Human Services -FDA, News and Events; March 2012; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm296488.htm
- About Boniva; Boniva.com; March 2012; http://www.boniva.com/boniva/about_boniva/default.htm
- Ibandronate, Boniva; MedicineNet.com; March 2012; http://www.medicinenet.com/ibandronate/page2.htm