Prescription PEG 3350 Laxatives Being Withdrawn from Market
September 5, 2018 – Bayer has announced that it intends to remove its prescription PEG 3350 laxative products from the market effective November 2, 2018. This decision follows the U.S. FDA’s withdrawal of approval for abbreviated new drug applications (ANDAs) for such products.
According to Bayer, the date of product withdrawal may change depending on appeals filed by ANDA holders in federal court. The FDA’s decision is based on Section 503(b) of the Federal Food, Drug, and Cosmetic Act, which prohibits the marketing of a drug over-the-counter (OTC) and by prescription (Rx) at the same time unless there is a meaningful difference between the OTC and Rx products. PEG 3350 laxatives first became available over the counter in 2006, when Bayer’s MiraLAX® (polyethylene glycol 3350 powder for solution) received FDA approval as an OTC treatment.
Bayer has stated it will make coupons available for patients switching from a prescription PEG 3350 product to MiraLAX, to help ease the transition.