Auro Pharma Receives USFDA Nod For Atrophic Vaginitis Inserts

Aurobindo Pharma has secured final approval from the US Food & Drug Administration (USFDA) to produce and sell Estradiol Vaginal Inserts USP, 10 mcg. This drug is bioequivalent and therapeutically equivalent to Novo Nordisk Inc.'s Vagifem, 10 mcg, and is slated for launch in Q2 FY25. Estradiol Vaginal Inserts USP, 10 mcg, is used to treat atrophic vaginitis caused by menopause. According to IQVIA, the market for this product is estimated to be worth $268 million for the twelve months ending in June 2024.

The pharmaceutical company now holds 521 ANDA approvals from the USFDA, comprising 504 final approvals and 17 tentative approvals. Aurobindo Pharma primarily focuses on the production and distribution of active pharmaceutical ingredients, generic medications, and related services. In Q4 FY24, the company saw a significant 79.5% increase in consolidated net profit, reaching Rs 908.75 crore, alongside a 17.1% rise in revenue from operations, totaling Rs 7,580.15 crore, compared to Q4 FY23.