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Aurobindo Receives FDA Approval for Etyqa (Estradiol and Norethindrone Acetate Tablets USP), 0.5 mg/0.1 mg and 1 mg/0.5 mg

Published: June 30, 2023

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Etyqa (Estradiol and Norethindrone Acetate Tablets USP), 0.5 mg/0.1 mg and 1 mg/0.5 mg. Aurobindo Pharma’s Etyqa (Estradiol and Norethindrone Acetate Tablets USP), are an AB-rated generic equivalent to the reference listed drug (RLD), Activella® Tablets manufactured by Amneal Pharmaceuticals LLC.

Etyqa (Estradiol and Norethindrone Acetate Tablets USP) are indicated for:

  • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
  • Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause
  • Prevention of Postmenopausal Osteoporosis.