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# Court Backs FDA in MiraLax OTC Decision
- URL: https://www.fdaweb.com/court-backs-fda-in-miralax-otc-decision/
- Published: 2018-10-31T12:00:00.000Z
- Updated: 2026-09-15T00:41:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142711

The DC Circuit Court of Appeals has ruled that FDA acted properly in denying a request for a hearing and withdrawing an ANDA submitted by Breckenridge Pharmaceutical and Nexgen Pharma for a generic version of Braintree Laboratories’ prescription MiraLax. The court [opinion](https://www.cadc.uscourts.gov/internet/judgments.nsf/666DDB61E850680385258336004ACB38/$file/18-1112-1757697.pdf?ref=fdaweb.com) noted that after FDA approved Braintree’s NDA for prescription MiraLax, it later approved that company’s NDA for an over-the-counter version,

The agency told Breckenridge and Nexgen that its approval of the over-the-counter version meant that the drug no longer met the criteria for a prescription drug unless there was a “meaningful difference” between the prescription and over-the-counter versions. The suit challenged FDA’s determination that no meaningful difference exists.

The court said that the agency found that on each of the factors pertinent to a meaningful difference, OTC and Rx MiraLax were identical or nearly so. “We conclude that FDA’s determination that prescription MiraLax is misbranded for lack of a ‘meaningful difference’ with OTC MiraLax is neither arbitrary or capricious,” the three-judge panel said.

The court also rejected the petitioners’ process-based challenges to FDA’s denial of a hearing on withdrawal of prescription MiraLax.