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# Regulatory Review Period Determined for Portrazza
- URL: https://www.fdaweb.com/regulatory-review-period-determined-for-portrazza/
- Published: 2018-02-20T12:00:00.000Z
- Updated: 2026-09-14T23:23:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140793

*Federal Register* notice: FDA has determined for patent extension purposes that the regulatory review period for Eli Lilly’s Portrazza (necitumumab) is 2,533 days. Of this time, 2,175 days occurred during the testing phase and 358 days during the approval phase. Portrazza is indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-02-20/pdf/2018-03345.pdf?ref=fdaweb.com).