Unfortunately I think approval is going to wait sometime yet. Heparin contamination and Indian drug companies are two big issues at the moment in the US. Neither may be closely related to Dr R or ACL Heparin but there is always guilt by association.
Two of many articles around are below.
http://www.eyeonfda.com/eye_on_fda/2011/02/house-energy-and-commerce-to-re-open-heparin-contamination-issue-after-house-votes-to-cut-fda-funding.html
Indian Drug Maker Faces Ban
http://postscript.communitycatalyst.org/?p=2250
My thoughts only, are the FDA sitting on this until the inquisition passes? That and they are making doubly sure that this one is 100% and won't come back and bite them.
I stopped holding my breath awhile back now.
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