The US launch of estradiol vaginal cream USP, 0.01%, Mylan N.V Global pharmaceutical leader has reported the primary generic version of Allergan’s Estrace cream.
Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is shown in the treatment of vulvar and vaginal atrophy.
“The approval and launch of estradiol vaginal cream strengthens our robust women’s healthcare portfolio and our commitment to helping women manage with their health over each phase of their lives, from contraception and hormone replacement treatment to specific disorders that are highly common in women, similar to hypothyroidism, said Mylan CEO Heather Bresch.
Mylan is presently one of only a few organizations that will offer Estradiol as an option across four delivery systems cream, gel, transdermal patch, and tablet.
This breadth enables us to deliver multiple options and, eventually, greater value to clients, healthcare professionals, and patients.
Additionally, for patients and the US healthcare system introduces first-time generic exhibits our leadership to create access to the high-quality drug.”
Mylan president Rajiv Malik included, “Topicals like estradiol vaginal cream are a great example of Mylan’s ability to bring to market complex products. We have made substantial investments in research and development of these difficult to- develop pharmaceuticals and believe this gives long-term maintainability to our business.”
Estrogens increase the risk of endometrial cancer, and should not be utilized for the prevention of cardiovascular disease or dementia. Estrogen use is related to an increased risk of stroke, DVT, and dementia in postmenopausal women.
Due to the risks related to estrogen use, they should be recommended at the lowest effective dosage and for the shortest duration.
As indicated by IQVIA, US sales of Estradiol vaginal cream USP-0.01% for the 12 months had approximately $449 million ending October 31, 2017.