In an FDA announcement today titled Approved First Generic for Apokyn Injection Cartridges Requires Separately Packaged Pen (here), the Agency noted that this is the first generic approved without a delivery device. While I am aware of other FDA approvals where an off-the-shelf autoinjector was available to inject a prefilled syringe (that can be procured and used separately), this is the first time I can remember a cartridge approval that requires a specific device not included as part of the ANDA approval.
The article goes on to say this first generic approval of Apokyn (apomorphine hydrochloride injection) drug cartridges to treat Parkinson’s disease comes with a hitch as FDA warns that:
“Prescribers and pharmacists should be aware that patients starting treatment with generic apomorphine hydrochloride injection will need to separately obtain the Apokyn Pen. This approval is for Sage Chemical Inc.’s application of the drug cartridges only, which are compatible for use with the Apokyn Pen, the brand-name pen injector. The Apokyn Pen is supplied by the brand manufacturer, is distributed and packaged separately, and is generally only dispensed through specialty pharmacies.”
This may have the tendency to put patients at the mercy of the specialty pharmacies and the influence of the innovator if it demands that the pen be sold only to brand-name cartridge buyers. I don’t know whether any arrangement has been discussed, but specialty pharmacies oftentimes have “interesting” arrangements with single-source customers. The “How Supplied” section of the approved label states, “[T]he pen injector is provided in a package with six needles and a carrying case” but does not indicate whether the pen is for sale separately. Hopefully patients will not experience difficulties in obtaining the branded pen for use with the generic cartridges.
