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# Rebinyn Regulatory Review Period Determined
- URL: https://www.fdaweb.com/rebinyn-regulatory-review-period-determined/
- Published: 2018-10-29T12:00:00.000Z
- Updated: 2026-09-15T00:41:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142689

*Federal Register* notice: FDA has determined for patent extension-related purposes the regulatory review period for Novo Nordisk’s Rebinyn (coagulation factor IX recombinant) glycopegylated), indicated for use in adults and children with hemophilia B. The regulatory review period has been determined to be 2,793 days, which includes 2,412 days that occurred during the testing phase, and 381 days during the approval phase. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-10-26/pdf/2018-23437.pdf?ref=fdaweb.com).