FDA Won’t Approve AstraZeneca’s Brilinta Without More Info

Published On: December 18th, 2010

AstraZeneca says it’s confident in its ability to respond to the FDA’s questions about a certain clinical trial of the drug.

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marydrozario : 505(b)(2) submissions underutilized. Data from public domain etc. Add certain clinical trials, 3 yrs market exclusivity. -WL

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