Pharmaceutical Business review

Mylan introduces generic Actonel tablets 150mg

The company secured final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for this product, which is indicated to treat and prevent osteoporosis in postmenopausal women.

According to IMS Health, Risedronate Sodium Tablets USP, 150mg, had US sales of about $171.6m for the 12 months ending 31 March 2014.

At present, the company has 303 ANDAs pending FDA approval representing $105.3bn in annual brand sales and 41 of these pending ANDAs are potential first-to-file opportunities, representing $25.4bn in annual brand sales, for the 12 months ending 31 December 2013.

The company offers a growing portfolio of more than 1,300 generic pharmaceuticals and several brand medications.

In addition, Mylan provides a wide range of antiretroviral therapies, upon which about 40% of HIV/AIDS patients in developing countries depend.

The company also operates one of the largest active pharmaceutical ingredient manufacturers and currently markets products in about 140 countries and territories.