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Avandia - FDA Information

Consumers Warned to Avoid Eating Raw Oysters from Southern Tip of Hood Canal in Washington State
The U.S. Food and Drug Administration is warning consumers not to eat raw oysters harvested from an area of the southern tip of Hood Canal in Washington after an outbreak of illness caused by Vibrio parahaemolyticus bacteria.
FDA Takes Action Against Iowa Dairy for Illegal Drug Residues Found in Cows
The FDA is concerned about the sale of animals for human food that may contain illegal levels of animal drugs because of the potential for adverse effects on human health.
FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on Internet as Treatments for High Cholesterol
The products may contain an unauthorized drug that could be harmful to health. The products are promoted as dietary supplements for treating high cholesterol.
FDA Issues Safety Alert on Avandia
Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes.
Index to Drug-Specific Information
Index to Drug-Specific Information Note: This Index does not include all FDA approved drugs. ...
Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information
Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Information This information is not current. The issues described in this...
Information for Healthcare Professionals: Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl)
Information for Healthcare Professionals Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Please see the Drug Information page for rosiglitazone . ...
Information for Healthcare Professionals: Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl)
Information for Healthcare Professionals Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) This information is not...
Approved Active Moieties to which FDA has issued a Written Request for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act
Approved Active Moieties to which FDA has issued a Written Request for Pediatric Studies under Section 505A of the Federal Food, Drug, and Cosmetic Act ...
Warning Letters and Untitled Letters to Pharmaceutical Companies 2007
Warning Letters and Untitled Letters to Pharmaceutical Companies 2001 These letters, sorted by month, are supplied by the CDER Freedom of...
Warning Letters and Untitled Letters to Pharmaceutical Companies 2007
Warning Letters and Untitled Letters to Pharmaceutical Companies 1999 These letters, sorted by month, are supplied by the CDER Freedom...
Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies
Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies as of January 15, 2008 Total Number of Drugs with Summaries Posted: 88 ...
New Drug Application (NDA) & Biologic License Application (BLA) Efficacy CY 2007
New Drug Application ( NDA) & Biologic License Application (BLA) Efficacy Supplements Approved ( CY 2007) Updated through November 30, 2007 ...
CDER News Items 2007
CDER News Items 2007 • October 10. FDA approves the first generic versions of Trileptal (oxcarbazepine), an anticonvulsant drug. • ...
Paragraph IV Patent Certifications
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Tentative Approvals - December 2004
Tentative Approvals - December 2004...
Tentative Approvals - November 2005
Tentative Approvals - December 2005 ...
CDER NME Approvals in Calendar Year 1999
CDER NME Approvals in Calendar Year 1999 Updated through December 31, 1999 ...
Patient Information Sheet for Avandia
Patient Information Sheet for Avandia Please click on the following link to open the...
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Avandia Case Evaluation Form

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YOUR CONTACT INFORMATION
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CASE INFORMATION
Why Was Avandia Prescribed?: *
What Dosage, in Milligrams?:
How Frequently Was Avandia Taken?:
Date Patient Began Taking Avandia:

Stopped Taking Avandia:

What Symptoms Were Experienced?: *
Heart Attack
Stroke
Heart Failure

 Death
Other
PPH
If "Other", Please Describe:
How Long Was it From the Last Dose to the Problems Appearing?:
    Within 1 Day 2 Days 3 Days
    More Than 3 Days Don't Know
Questions/Comments:

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YOUR CONTACT INFORMATION
First Name: *
Last Name: *
E-mail Address: *
Address:
City:
State: *
Zipcode:
Phone: -- xtn

CASE INFORMATION
Why Was Avandia Prescribed?: *
What Dosage, in Milligrams?:
How Frequently Was Avandia Taken?:
Date Patient Began Taking Avandia:

Stopped Taking Avandia:

What Symptoms Were Experienced?: *
Heart Attack
Stroke
Heart Failure

 Death
Other
PPH
If "Other", Please Describe:
How Long Was it From the Last Dose to the Problems Appearing?:
    Within 1 Day 2 Days 3 Days
    More Than 3 Days Don't Know
Questions/Comments:
This form is secure and encrypted. More information about secure forms and your privacy here.