Pharmacy Daily | FDA approvals

The US Food and Drug Administration has approved the first adjuvanted vaccine for the prevention of H5N1 avian influenza. The vaccine is for use in people 18 years of age and older who are at increased risk of exposure to the H5N1 influenza virus. It’s not intended for commercial availability, but has been purchased from GSK offshoot ID Biomedical in order to supplement the US National Stockpile. The FDA has also approved Olysio (simprevir) which is a new therapy to treat chronic hepatitis C. Olysio is a protease inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate, and is to be used as a component of a combination antiviral treatment regimen. Nexavar (sorafenib) has also been FDA-approved to treat late stage differentiated thyroid cancer. Other FDA approvals include four diagnostic devices which can be used for “high throughput gene sequencing,” with two of the systems able to be used to detect DNA changes which can result in cystic fibrosis.

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