FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Lannett Petitions for Stay of Glycolax Withdrawal Order

April 17, 2018

Lannett filed an emergency petition with the FDA requesting postponement of the agency’s withdrawal order for its ANDA for Glycolax pending a court ruling.

The withdrawal order, initiated by the agency after the drug shifted from prescription-only to over-the-counter, calls for Glycolax (polyethylene glycol), a constipation medication, to be stripped of FDA approval on the grounds that its drug products are misbranded.

The emergency petition requests the withdrawal order be stayed until 30 days after the D.C. Circuit makes a decision regarding judicial review of the agency’s order.

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