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Aurobindo Receives FDA Approval for Estradiol Vaginal Inserts USP, 10 mcg

Published: August 02, 2024

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Estradiol Vaginal Inserts USP, 10 mcg. Aurobindo Pharma’s Estradiol Vaginal Inserts, are an AB-rated generic equivalent to the reference listed drug (RLD), Vagifem manufactured by Novo Nordisk Inc.

Estradiol Vaginal Inserts are indicated for:

  • The treatment of atrophic vaginitis due to menopause.