Perrigo asserted FDA’s approval for generic version of Estrace Cream

U.S Food and Drug Administration approved Perrigo Company’s generic version of Estrace Cream anticipated to be launched in the second quarter of the year. Constituents of the cream are estradiol vaginal cream, USP, 0.01%). This product will be marketed by Perrigo’s partner, Impax Laboratories, Inc.

According to IMS health, Estrace Cream is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Market sales of Estrace Cream over the last 12 months were approximately $457 million.

Perrigo Executive Vice President and President Rx Pharmaceuticals John Wesolowski stated, “This is another example of our continuing commitment to delivering extended topical products to patients at more affordable prices.”