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# Regulatory Review Period for Millennium’s Ninlaro
- URL: https://www.fdaweb.com/regulatory-review-period-for-millenniums-ninlaro/
- Published: 2018-01-22T12:00:00.000Z
- Updated: 2026-09-14T23:16:02.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140554

*Federal Register* notice: FDA has determined for patent extension purposes that the regulatory review period for Millennium Pharmaceuticals’ Ninlaro (ixazomib) was 2,538 days. Of this time, 2,404 days occurred during the testing phase and 134 days occurred during the approval phase. The product is indicated for use in combination with lenalidomide and dexamethasone for treating patients with multiple myeloma who have received at least one prior therapy. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-01-22/pdf/2018-00994.pdf?ref=fdaweb.com).