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# FDA Denies Persion Zohydro ER Petition
- URL: https://www.fdaweb.com/fda-denies-persion-zohydro-er-petition/
- Published: 2020-01-22T12:00:00.000Z
- Updated: 2026-09-14T15:59:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145900

FDA has denied an 8/29/19 Persion Pharmaceuticals petition asking that the agency take two specific actions regarding ANDAs for generic Zohydro ER (hydrocodone bitartrate) extended-release capsules. The petition asked that FDA require: 

- that any ANDA for generic Zohydro ER contain bioequivalence data from testing in hepatically impaired subjects; and
- that any ANDA for generic Zohydro ER contain the same information in its labeling as the labeling of the reference-listed drug concerning the administration of the drug to patients with hepatic impairment.

The agency denial [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2019-P-4140-0016&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says that FDA does not agree with Persion’s contention that the Zohydro ER formulation significantly minimizes pharmacokinetic variation in patients with mild or moderate hepatic impairment and that a demonstration of bioequivalence in healthy subjects would not rule out clinically significant pharmacokinetic differences between Zohydro ER and a proposed generic in hepatically-impaired patients.

FDA says the petition provided no scientific support for the assertion that the Zohydro ER formulation affects pharmacokinetic differences in hepatically-impaired patients.

FDA also disagreed with the company’s conclusion that Zohydro ER is unexpectedly well-suited for individuals with hepatic impairment, noting that it has approved three NDAs for extended-release, single active ingredient, hydrocodone products, including Zohydro ER, with similar or more restrictive labeling. “Thus, we do not agree that Zohydro ER has unexpected PK properties in individuals with hepatic impairment,” it says.

FDA also denied the petition with respect to the second request in terms of labeling information, saying that some omission of information is acceptable if it does not render the proposed generic drug less safe or effective than the reference-listed drug for the non-protected conditions of use that remain in the labeling.

The letter says the agency approved on the date of its response an ANDA for a product referencing Zohydro ER that contains the same labeling instructions for administration to patients with hepatic impairment as the Zohydro label. Thus, FDA did not have to evaluate a proposed omission of labeling instructions in that instance.