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# Endo Wants Generic Epinephrine Restrictions
- URL: https://www.fdaweb.com/endo-wants-generic-epinephrine-restrictions/
- Published: 2025-02-13T12:00:00.000Z
- Updated: 2026-09-14T14:53:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158657

Endo is petitioning FDA to impose restrictions on 505(b)(2) and 505(j) applications for pharmaceutical equivalents of specific ready-to-use concentrations of intravenous epinephrine covered by an Endo NDA that FDA approved on 4/21/2023\. The company’s 2/12 petition specifically asks FDA to:

- refrain from receiving for filing or approving any 505(b)(2) application that was filed after 4/21/2023, covers at least one product that is pharmaceutically equivalent to at least one product covered by the Endo NDA and does not reference the Endo NDA;
- refrain from receiving for filing or approving any 505(j) application that was filed after 4/21/2023, covers at least one product that is pharmaceutically equivalent to at least one product covered by the Endo NDA and does not reference the Endo NDA; and
- deny any petition that seeks a change previously approved in Endo’s NDA and which product does not reference Endo’s NDA.

The petition concludes that “FDA’s clear regulations and long-held policies demonstrate that an ANDA or 505(b)(2) application must reference the NDA of a previously approved pharmaceutical equivalent.”