First Generic Version of Apokyn Drug Cartridges Gets FDA Approval
The Food and Drug Administration (FDA) has approved Sage Chemical’s generic version of the Apokyn (apomorphine hydrochloride injection) drug cartridges. The approval is only for the drug cartridges, which are compatible with the Apokyn Pen, the brand name pen injector.
Apomorphine hydrochloride injection is indicated for the acute, intermittent treatment of hypomobility, off episodes (end-of-dose wearing off and unpredictable on/off episodes) associated with advanced Parkinson disease. The product is supplied as a 30mg/3mL sterile solution in single-patient use cartridges.
Health care professionals should be aware that patients starting treatment with generic apomorphine hydrochloride injection will need to separately obtain the Apokyn Pen, which is distributed and packaged separately by the brand manufacturer. The Apokyn Pen is generally only dispensed through specialty pharmacies.
Prior to being prescribed generic apomorphine hydrochloride injection, patients should first obtain the prescribed Apokyn Pen.
ReferenceApproved first generic for Apokyn injection cartridges requires separately packaged pen. News release. US Food and Drug Administration. February 24, 2022. Accessed February 25, 2022.
https://www.fda.gov/drugs/drug-safety-and-availability/approved-first-generic-apokyn-injection-cartridges-requires-separately-packaged-pen
https://www.empr.com/home/news/generics-news/first-generic-version-of-apokyn-drug-cartridges-gets-fda-approval/
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