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# Myalept Regulatory Review Period for Patent Extension
- URL: https://www.fdaweb.com/myalept-regulatory-review-period-for-patent-extension/
- Published: 2016-09-23T12:00:00.000Z
- Updated: 2026-09-14T21:34:33.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136902

*Federal Register* Notice: FDA has determined the regulatory review period for an Amylin Pharmaceuticals NDA for Myalept (metreleptin for injection) that applies to a patent extension for the product. FDA determined that the applicable regulatory review period is 6,509 days. To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-09-23/pdf/2016-22935.pdf?ref=fdaweb.com).