Impax unveils generic Estrace Cream USP, 0.01%
9 April 2018 -

Pharmaceutical company Impax Laboratories Inc (NASDAQ:IPXL) reported on Friday the availability of the generic version of Estrace Cream (estradiol vaginal cream, USP, 0.01%).

US Food and Drug Administration final approval for the generic Estrace Cream was awarded to the company's manufacturing and development partner, Perrigo Company plc (NYSE:PRGO)(TASE:PRGO) in late January.

For the 12 months ending January 2018, Estrace Cream had annual US sales of approximately USD469m, according to IQVIA.

There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer, concluded the company.