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Mylan releases Generess Fe generic in U.S.

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POTTERS BAR, England, and PITTSBURGH — Mylan N.V. has launched norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and ferrous fumarate chewable tablets (75 mg) in the United States.

Mylan said Tuesday that its product is the first generic version of Warner Chilcott’s Generess Fe tablets, an oral contraceptive, and entitles it to 180 days of marketing exclusivity.

Mylan partner Famy Care Ltd. received final approval from the Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for the generic product, which mark Mylan’s ninth oral contraceptive product launch in the U.S.

Norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and ferrous fumarate chewable tablets (75 mg) totaled U.S. sales of about $114.7 million in the 12 months ended Dec. 31, 2014, according to IMS Health data reported by Mylan.


ECRM-08-202222


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