Close to 10 years ago, when Serono, in an effort to get a bigger piece of the pediatric growth hormone market, teamed up with Bioject to offer a needle-free option, the combination of the injection technology and the injectable had to be approved by the FDA despite the fact that the injection technology AND the HGH were both approved. (Serono's market share went from something like 6% to 20% within 2-3 years). This is and has been an ongoing issue for Bioject. They have approved technology for delivery of injectables but, the FDA in their infinite wisdom, seem to be saying that every application has to be approved when it is used with Bioject's (approved) solution.
Things that make one go hmmmmm.