First generic version of Generess Fe launched in USA by Mylan

7 April 2015

US generic drugmaker Mylan (Nasdaq: MYL) says it has launched norethindrone and ethinyl estradiol tablets (chewable) and ferrous fumarate Tablets, (chewable), which is the generic version of Warner Chilcott's Generess Fe, a 28-day regimen indicated for use by women to prevent pregnancy. Warner Chilcott is now part of Ireland-headquartered generics drug major Actavis (NYSE: ACT).

Mylan's partner Famy Care received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for this product, which is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Mylan's immediate shipment of the generic drug represents the company's ninth oral contraceptive product launch in the USA.

Norethindrone and ethinyl estradiol 0.8mg/0.025mg and ferrous fumarate 75mg had US sales of around $114.7 million for the 12 months ending December 31, 2014, according to IMS Health data quoted by Mylan.

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