Whoops, looks like that was their July response. Judging by the this new release from Hartley it seems that they will need to do a bit of testing. I still wonder why, I thought most IV drugs come in Glass bottles. Maybe it is to do with the manufacturing process? Importantly, the FDA don't have any issues with the drug itself, surely the packaging could just be changed if it is a problem?
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- Ann: AFT update on Maxigesic IV US registration filing
Ann: AFT update on Maxigesic IV US registration filing, page-3
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