FDA approves first generic ibandronate sodium osteoporosis drugs

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FDA approves first generic ibandronate sodium osteoporosis drugs

Genéricos/Novedades | Posted 30/03/2012 0 Post your comment

FDA announced on 19 March 2012 the approval of the first generics of GlaxoSmithKline’s and Roche’s postmenopausal osteoporosis drug Boniva (ibandronate sodium).

FDA has approved 150 mg generic versions of the once-monthly medication to treat or prevent osteoporosis in women after menopause from Canada-based Apotex and India-based companies Mylan and Orchid.

Osteoporosis can affect both men and women and according to the National Institutes of Health, more than 40 million people in the US either already have osteoporosis or are at high risk due to low bone mass.

Ibandronate sodium is designed to decrease the activity of cells that cause bone loss after menopause, by slowing the natural processes that dissolve bone tissue.

Mr Keith Webber, Deputy Director of the Office of Pharmaceutical Science at the FDA’s Center for Drug Evaluation and Research, commented that osteoporosis is ‘a disease that can be prevented and treated’; however, ‘it is important to have affordable treatment options’.

According to IMS Health, Boniva had US sales of approximately US$517 million in 2011. The patent for Boniva expired in March 2012 and Mylan has announced that it will be shipping the product immediately.

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Source: FDA, Mylan