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# Regulatory Review Determined for Ibrance
- URL: https://www.fdaweb.com/regulatory-review-determined-for-ibrance/
- Published: 2018-02-14T12:00:00.000Z
- Updated: 2026-09-14T23:22:28.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140762

*Federal Register* notice: FDA has determined for patent extension purposes that the regulatory review period for Warner-Lambert’s Ibrance (palbociclib) is 3,954 days. Of this time, 3,779 days occurred during the testing phase and 175 days during the approval phase. Ibrance is indicated for treating of hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. Its use is approved in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women, or fulvestrant in women with disease progression following endocrine therapy. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-02-14/pdf/2018-03029.pdf?ref=fdaweb.com).