Prescription Polyethylene Glycol 3350; Denial of a Hearing and Order Withdrawing Approval of Abbreviated New Drug Applications

摘要

The Commissioner of Food and Drugs (the Commissioner) is denying requests for a hearing and issuing an order withdrawing approval of abbreviated new drug applications (ANDAs) for certain prescription laxatives with the active ingredient polyethylene glycol 3350 (PEG 3350), listed in this document, because the drug products are misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act).