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# FDA Denies Janssen Invega Sustenna Petition
- URL: https://www.fdaweb.com/fda-denies-janssen-invega-sustenna-petition/
- Published: 2021-07-14T12:00:00.000Z
- Updated: 2026-09-14T17:06:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149707

FDA has denied a 5/9/13 Janssen petition asking that the agency apply specific bioequivalence parameters to any ANDA submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FFDCA) or NDA submitted under section 505(b)(2) that references the company’s Invega Sustenna (paliperidone palmitate). The company also submitted three petition supplements asking that if FDA does not require the requested bioequivalence studies, it make specific modifications sought by Janssen to the draft paliperidone guidance.

In its denial [letter](https://downloads.regulations.gov/FDA-2013-P-0608-0008/attachment%5F1.pdf?ref=fdaweb.com), FDA says it does not agree that a single-dose *in vivo* bioequivalence study with specific bioequivalence parameters is necessary to detect clinically meaningful differences between a proposed generic product and the reference-listed product. The agency says it also does not agree with Janssen’s proposed changes to the steady-state bioequivalence study recommendations in the draft paliperidone guidance.