Aurobindo Pharma Ltd. reported that it has received final approval from the US Food and Drug Administration to manufacture and market estradiol vaginal inserts, according to an exchange filing on BSE.
The company said their estradiol vaginal inserts have been developed with the treatment of atrophic vaginitis due to menopause in mind.
The firm said that their product is "bioequivalent and therapeutically equivalent to the reference listed drug, VAGIFEM, of Novo Nordisk Inc.".
The product will be launched in the second quarter of fiscal 2025.
The product has an estimated market size of $268 million for the twelve months ending June 2024, according to IQVIA.
The company reported having a total of 521 abbreviated new drug application approvals, out of which 504 are final approvals and 17 are tentative approvals from the US FDA.
Shares of Aurobindo Pharma fell over 1.38% to trade at Rs 1,421.25 apiece, as compared to a 0.26% fall in the NSE Nifty 50.
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