Zdrowie i gospodarka · 24/10/2008

FDA Proposes Withdrawal of Approval for Certain Prescription Polyethylene Glycol 3350 Drug Products

The Food and Drug Administration (FDA) is proposing to withdraw approval of several prescription polyethylene glycol 3350 (PEG 3350) drug products, which were previously approved as abbreviated new drug applications (ANDAs), due to the switch of MiraLax from prescription-only to over-the-counter use, following the approval of a new drug application (NDA) for MiraLax in 2006.