Mylan introduces Norethindrone and Ethinyl Estradiol tablets in US

These tablets are the generic version of US-based pharmaceutical firm Warner Chilcott’s Generess Fe tablets.

The US Food and Drug Administration (FDA) has also granted final approval for the company’s partner Famy Care for its abbreviated new drug application (ANDA) for this product, which is designed for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

According to IMS Health, Norethindrone and Ethinyl Estradiol tablets and Ferrous Fumarate tablets had US sales of around $114.7m for the 12 months ending 31 December 2014.

Around 269 of Mylan ANDAs that represent $104.1bn in annual sales are still awaiting clearance from the FDA, with 44 of them being potential first-to-file opportunities, signifying $27.3bn in annual brand sales, for the year ending 30 June 2014.

The company offers a growing portfolio of more than 1,400 generic pharmaceuticals and several brand medications.

Additionally, the company provides a wide range of antiretroviral therapies, upon which about 40% of HIV/AIDS patients in developing countries depend.

Mylan also operates one of the largest active pharmaceutical ingredient manufacturers and currently markets products in about 145 countries and territories.