U.S., EU Grant Accelerated Reviews of Merck Hepatitis Drug
January 11, 2011
The U.S. Food and Drug Administration (FDA) has granted an accelerated review of Merck & Co.'s experimental hepatitis C drug boceprevir, a status designated for drugs that represent a significant medical advancement or address a public health need.
Merck said it submitted boceprevir's application to U.S. and EU regulators last year. FDA generally aims to complete reviews of priority applications within six months, compared with the standard 10-month review period.
Wall Street Journal
01.06.2011; Peter Loftus
This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. Visit the CDC's website to find out more about their activities, publications and services.
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