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# Regulatory Review Period for Shionogi’s Symproic
- URL: https://www.fdaweb.com/regulatory-review-period-for-shionogis-symproic/
- Published: 2019-04-12T12:00:00.000Z
- Updated: 2026-09-15T01:20:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143856

*Federal Register* notice: FDA has determined the regulatory review period for Shionogi’s Symproic (naldemedine tosylate) for treating opioid-induced constipation in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. The regulatory review period is 2,523 days, including 2,157 days that occurred during the testing phase and 366 days during the approval phase. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-07459.pdf?ref=fdaweb.com).