FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Appeals Court Affirms FDA on Denial of Prescription Generics for Bayer Laxative

Nov. 9, 2018

A federal appeals court has backed up the FDA’s decision to block prescription generics of Bayer’s MiraLax after the branded version switched to over-the-counter status.

The FDA approved the first NDA for OTC MiraLax in 2006 saying the product no longer met the criteria for a prescription drug because there was no meaningful difference between the prescription and OTC versions. The agency bases its determination of meaningful differences on the indication, strength, route of administration, dosage form and patient population.

Generic drugmakers Nexgen Pharma and Breckenridge Pharmaceutical argued that the market still needed a prescription version of the laxative so doctors could act as gatekeepers, citing increased hospitalizations and deaths in the wake of the OTC’s approval.

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