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# FDA Orders PEG 3350 ANDAs Off Market Due to OTC Switch
- URL: https://www.fdaweb.com/fda-orders-peg-3350-andas-off-market-due-to-otc-switch/
- Published: 2018-04-02T12:00:00.000Z
- Updated: 2026-09-14T23:56:55.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141118

*Federal Register* notice: FDA has issued an order withdrawing approval of ANDAs for certain prescription laxatives with the active ingredient polyethylene glycol 3350 (PEG 3350) because the drug products are misbranded. The order is in response to a change in Braintree Labs’ MiraLAX’s status from prescription to nonprescription status. FDA explained that its regulations do not permit both prescription and nonprescription versions of the same drug product to be marketed at the same time. The agency has notified the PEG 3350 ANDA holders that their prescription products, which bear the “Rx only” symbol, are misbranded and may not be lawfully marketed. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-04-02/pdf/2018-06537.pdf?ref=fdaweb.com).