MiraLAX Generics Get FDA Reprieve Despite Bayer Objections

Law360 (April 20, 2018, 7:13 PM EDT) -- Sales of generic versions of popular constipation drug MiraLAX will be allowed for an extra six months, the U.S. Food and Drug Administration revealed Friday, rejecting opposition from Bayer AG and reversing the agency's own recent order requiring sales to end promptly.

In a letter released Friday, the FDA acceded to some requests from four companies — Breckenridge Pharmaceutical Inc., Nexgen Pharma Inc., Lannett Co. Inc. and Paddock Laboratories Inc. — that sell generic, prescription versions of Bayer's MiraLAX, or polyethylene glycol 3350.

The FDA on April 2 ordered a halt to sales by May 2, but extended that deadline to...

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