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Mylan gets US FDA approval for 1st generic of Allergan's Estrace Cream

Mylan NV launched its Estradiol vaginal cream 0.01% in the U.S. after final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for the product to treat vulvar and vaginal atrophy.

Estradiol vaginal cream 0.01% is the first generic version of Allergan plc's Estrace Cream.

Estradiol vaginal cream 0.01% had U.S. sales of about $449 million for the 12 months ending Oct. 31, according to IQVIA.