Aurobindo Pharma announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Estradiol Vaginal Inserts USP, 10 mcg.
The approved drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vagifem, 10 mcg of Novo Nordisk Inc. The product will be launched in Q2 FY25.Estradiol Vaginal Inserts USP, 10 mcg is indicated for the treatment of atrophic vaginitis due to menopause.
The approved product has an estimated market size of $268 million for the twelve months ending June 2024, according to IQVIA.
The drug maker now has a total of 521 ANDA approvals (504 Final approvals and 17 tentative approvals) from USFDA.
Aurobindo Pharma is principally engaged in manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals and related services.
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The pharma major reported 79.5% jump in consolidated net profit to Rs 908.75 crore on a 17.1% rise in revenue from operations to Rs 7,580.15 crore in Q4 FY24 over Q4 FY23.
The scrip fell 1.49% to close at Rs 1,399.60 on Tuesday, 6 August 2024.
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