AUROBINDO PHARMA; Co. received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Estradiol Vaginal Inserts USP, 10 mcg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VAGIFEM 10 mcg of Novo Nordisk Inc. The product will be launched in Q2FY25.
The approved product has an estimated market size of USS 268 million for the twelve months ending June 2024, according to IQVIA. Aurobindo Pharma now has a total of 521 ANDA approvals (504 Final approvals and 17 tentative approvals) from USFDA.
Estradiol Vaginal Inserts USP, 10 mcg is indicated for the treatment of atrophic vaginitis due to menopause.