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# Mallinckrodt Petitions FDA on Inomax Follow-on Products
- URL: https://www.fdaweb.com/mallinckrodt-petitions-fda-on-inomax-follow-on-products/
- Published: 2017-07-14T12:00:00.000Z
- Updated: 2026-09-14T22:34:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139137

Mallinckrodt has filed a [citizen petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-4174-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) asking FDA to assure that follow-on drug products citing its Inomax (nitric oxide) 800 ppm for inhalation as the reference listed drug include features necessary for the safe and effective administration of inhaled nitric oxide. Two previous petitions seeking similar actions were earlier rejected by the agency because no generic applications were ready for approval at the time a response to the petitions were due under its regulations. The current petition asks FDA to undertake a “careful evaluation of the design and operation of the associated delivery system to assure any follow-on product is equivalent to the Inomax delivery system, and that it includes the same critical safety features.