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# Apokyn ANDAs Should Cover Drug and Device Parts: Petition
- URL: https://www.fdaweb.com/apokyn-andas-should-cover-drug-and-device-parts-petition/
- Published: 2019-07-10T12:00:00.000Z
- Updated: 2026-09-15T01:36:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144502

U.S. WorldMeds, which holds an NDA for Apokyn (apomorphine hydrochloride injection) indicated for acute, intermittent treatment of some aspects of Parkinson’s disease, says FDA should require that any ANDA for a generic version of Apokyn seek approval of both its drug and device constituent parts. The company says it submitted the [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2019-P-3192-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) “because FDA has not clarified whether the agency will approve an ANDA for only the drug constituent part of a drug-device combination product that is approved in an NDA.”

According to U.S. WorldMeds, an ANDA cannot be approved for only the drug constituent part because the device constituent part is an integral part of the reference-listed drug, and an ANDA applicant seeking approval of the drug constituent part only would be unable to satisfy the requirements to establish equivalency to the reference-listed drug product as a whole.

The petition says the issue of whether FDA will approve an ANDA only for the drug constituent part of a drug-device combination that is approved in an FDA — and if so, under what circumstances — is an issue that extends to products beyond Apokyn and thus the agency should develop a policy framework setting forth its position on the issue to reduce uncertainty for innovators, generic drug developers, and other stakeholders.