Aurobindo Pharma secures USFDA’s approval for Estradiol Vaginal Inserts

07 Aug 2024 Evaluate

Aurobindo Pharma has 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 $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.

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.


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