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FDA Approves Generic Everolimus Tablets

Kristi Rosa
Published: Tuesday, Dec 10, 2019

The FDA has approved 2 abbreviated new drug applications (ANDAs) for everolimus (Afinitor) tablets for the treatment of patients with advanced hormone receptor–positive, HER2-negative breast cancer in postmenopausal women; advanced renal cell carcinoma; progressive neuroendocrine tumors (NETs) of pancreatic origin; and progressive, well-differentiated, non-functional NETs of gastrointestinal or lung origin that are unresectable; and renal angiomyolipoma and tuberous sclerosis complex.



  1. US Food and Drug Administration. First generic drug approvals. Accessed December 10, 2019.
  2. US Food and Drug Administration. Generic drugs: overview & basics. Accessed December 10, 2019.
  3. Yao JC, Shah MH, Ito T, et al. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med. 2011;364(6):514-523. doi: 10.1056/NEJMoa1009290.
  4. Baselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012;366(6):520-529. doi: 10.1056/NEJMoa1109653.
  5. Yao JC, Fazio N, Singh S, et al. Everolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-4): a randomised, placebo-controlled, phase 3 study. Lancet. 2016;387(10022):968-977. doi: 10.1016/S0140-6736(15)00817-X.
  6. Endo launches generic version of Afinitor (everolimus) tablets in the United States [news release]. Dublic, Ireland: Endo International plc; December 10, 2019. Accessed December 10, 2019.

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