FDA rules active in MiraLax can only be marketed as OTC
The Food and Drug Administration earlier this month effectively eliminated any Rx-only competition to Bayer’s OTC laxative MiraLax (polyethylene glycol 3350).
The active ingredient in MiraLax had been approved for sale without a prescription nearly 12 years ago, but since that time, some manufacturers of products containing the identical ingredient for the same use, refused to withdraw their Rx-labeled products from the market and to re-apply for OTC status, as is required under the Federal Food, Drug, and Cosmetic Act.
“Consumers today are more empowered than ever to take their health into their own hands with an increasing array of choice and access to safe and effective over-the-counter medicines. The order confirms the same ingredient, absent a meaningful difference (such as the use or strength), may not be prescription and OTC at the same time,” the Consumer Healthcare Products Association stated in a release issued earlier this week. “This week’s FDA action resolves any remaining questions on this matter and reminds manufacturers to respect the formal procedures underpinning the Rx-to-OTC switch process and to work cooperatively to honor these regulations to prevent consumer confusion in the marketplace.”
The ruling may drive more consumers in search of the OTC laxative to the retail pharmacy. For the 52 weeks ended Nov. 5, 2017, sales of MiraLax across total U.S. multi-outlets totaled $205.2 million, up 3.3%.
FDA’s decision impacts five manufacturers with PEG 3350 ANDA approvals, including Kremers Urban Pharmaceuticals, Breckenridge Pharmaceutical, Nexgen Pharma, Paddock Laboratories and Teva Pharmaceutical.
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