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# Regulatory Review Period for GSK’s Nucala
- URL: https://www.fdaweb.com/regulatory-review-period-for-gsks-nucala/
- Published: 2016-12-13T12:00:00.000Z
- Updated: 2026-09-14T21:54:32.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137554

*Federal Register* Notice: FDA has determined the regulatory review period for patent extension purposes of GlaxoSmithKline’s Nucala (mepolizumab) for use with other asthma medicines as maintenance treatment in patients 12 years and older is 6,862 days. Of this, 6,496 days occurred during the testing phase, while 366 days occurred during the approval phase. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-12-13/pdf/2016-29838.pdf?ref=fdaweb.com).