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# Polyethylene Glycol 3350 Approval Withdrawals Stayed
- URL: https://www.fdaweb.com/polyethylene-glycol-3350-approval-withdrawals-stayed/
- Published: 2018-07-30T12:00:00.000Z
- Updated: 2026-09-15T00:22:39.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141993

*Federal Register* notice: FDA has extended until 11/2 the effective date of its order withdrawing approval of ANDAs for the prescription laxative polyethylene glycol 3350\. In April, FDA received petitions for a stay on behalf of four ANDA holders: Breckenridge Pharmaceutical and Nexgen Pharma, who submitted a joint petition; Lannett; and Paddock Laboratories. In response, the agency granted a temporary, discretionary stay based on information submitted by the ANDA holders. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-07-30/pdf/2018-16148.pdf?ref=fdaweb.com).