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# FDA Denies US WorldMeds Apokyn Petition
- URL: https://www.fdaweb.com/fda-denies-us-worldmeds-apokyn-petition/
- Published: 2019-11-27T12:00:00.000Z
- Updated: 2026-09-14T15:54:39.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5145609

FDA has denied without comment a 7/1 US WorldMeds petition asking that the agency: 

- require any ANDA referencing the company’s Apokyn (apomorphine hydrochloride) injection to seek approval of both the drug and medical device constituent parts of Apokyn; and
- establish a policy framework clarifying the circumstances, if any, under which the drug constituent part of a generic drug-device combination product can be approved in an ANDA that does not also seek approval of the device constituent part.

Apokyn is supplied by US WorldMeds in a cartridge that is used with a manual reusable multiple-dose pen injector.

The FDA denial [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2019-P-3192-0029&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says the law requires the agency to take final action on the petition within 150 days of submission. Thus, since FDA has made no final determination on whether to approve or not approve any ANDA referencing Apokyn, it is denying the first request in the petition without comment. And since the second request would take FDA more than 150 days to evaluate and act on, it also is being denied without comment.