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Aurobindo Pharma’s JV, Eugia Pharma receives FDA approval for Tamoxifen Citrate Tablets USP, 10 mg and 20 mg

Published: August 14, 2020

East Windsor, N.J. – Aurobindo Pharma’s JV, Eugia Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Tamoxifen Citrate Tablets USP, 10 mg and 20 mg. Aurobindo’s  JV, Eugia Pharma Tamoxifen Citrate Tablets USP, 10 mg and 20 mg. are an AB-rated generic equivalent to the reference listed drug (RLD), Nolvadex® Tablets, 10 mg and 20 mg, of AstraZeneca Pharmaceuticals LP.

Tamoxifen Citrate Tablets USP are indicated for:

  • Treatment of metastatic breast cancer in women and men.
  • Treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation.
  • Reducing the risk of invasive breast cancer.