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Aurobindo Receives FDA Approval for Anastrozole Tablets USP, 1 mg

Published: July 31, 2020

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Anastrozole Tablets USP, 1 mg. Aurobindo’s Anastrozole Tablets USP, 1 mg are an AB-rated generic equivalent to the reference listed drug (RLD), Arimidex Tablets, 1 mg, of ANI Pharmaceuticals, Inc.

Anastrozole Tablets are indicated for:

  1. For adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.
  2. Indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer.
  3. Indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.