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Efficacy of the Priority Review Voucher Program.
Experience With the Priority Review Voucher Program for Drug Development.
This leaves the product on track for end-2017 approval in the US assuming Priority Review.
Drugs accepted for priority review usually take six months to approve.
In August 2015, United Therapeutics sold a priority review voucher to AbbVie for $350 million.
Most drugs that, like Gleevec, are granted a priority review, take six months to approve.
Lilly said the F.D.A. still intended to give Xigris priority review, with an Oct. 27 deadline for completing the process.
Pfizer boasted that the FDA had granted "priority review" for a drug, crizotinib, that treats some types of lung cancer.
The company said it had asked for a decision within about six months, a so-called priority review that the agency often grants for cancer medicines.
The Food and Drug Administration has granted priority review status to Somavert, an injected drug developed by Sensus for treating a rare growth hormone disorder.
The Food and Drug Administration has granted priority review to the Sanofi drug because there are so few safe and effective medicines for atrial fibrillation.
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