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January 30, 2012 Name
Application
Date REMS Approved
REMS Components(All REMS include timetable for assessment)
Abstral (fentanyl) Sublingual Tablets (PDF – 2MB)1 Updated!
NDA 22-510/S-003
1/7/2011;
modified 12/28/2011
medication guide,...
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January 30, 2012
Today, Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma,...
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January 27, 2012
Drug helps keep cancer from progressing
The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced...
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January 20, 2012
Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a...
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January 17, 2012
Helps lower high blood levels of the chemotherapy drug
The U.S. Food and Drug Administration today approved Voraxaze (glucarpidase) to treat...
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January 4, 2012
Agency issues order prohibiting certain uses in food-producing animals
The U.S. Food and Drug Administration today issued an order that prohibits...
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December 29, 2011
The U.S. Food and Drug Administration today approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal...
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December 21, 2011
Isentress (raltegravir) was approved today by the U.S. Food and Drug Administration for use with other antiretroviral drugs for the...
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December 16, 2011
The U.S. Food and Drug Administration today approved a medical device that supports the weakened heart of children with heart...
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December 16, 2011
Draft guidance aimed to address the historic underrepresentation of women in clinical studies was issued by the U.S. Food and...
