Drugmakers Assail FDA For Nixing Generic Laxative Approval

Law360 (April 10, 2018, 9:01 PM EDT) -- Two drugmakers are attacking the U.S. Food and Drug Administration for rescinding approvals of generic versions of a Bayer AG laxative, warning of higher costs and "serious medical ramifications" for patients.

Breckenridge Pharmaceutical Inc. and Nexgen Pharma Inc. voiced the criticism in a citizen petition released Monday. The petition, which threatened a legal challenge, urged the FDA to delay its scheduled withdrawal of approvals for their generic versions of Bayer's MiraLAX, or polyethylene glycol 3350.

MiraLAX won approval in 1999 as a prescription drug, with generic versions entering the market later. It eventually converted to an over-the-counter drug. The FDA generally...

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