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FDA News

The FDA Advisories and Press Statements listed here may have special relevance to the care of children. For a comprehensive listing of Advisories, Press Releases, and Talk Papers, visit the FDA Web site at www.fda.gov. No official endorsement of the content by the AAP is provided or should be inferred.

 

News Releases, Statements, and Safety Alerts:

Relenza (zanamivir) MedWatch alert (April 2, 2008)

Early Communcation About an Ongoing Safety Review of Montelukast (Singulair) (March 28, 2008)

FDA issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine Containing Hydrocodone (March 11, 2008)

Tamiflu (oseltamivir phosphate) MedWatch alert (March 4, 2008)

FDA Approves Zyrtec for Nonprescription Use in Adults and Children (November 21, 2007)

FDA Takes Action to Stop Marketing of Unapproved Hydrocodone Products (September 28, 2007)

FDA Approves Lamasil for Pediatric Treatment of Scalp Ringworm (September 28, 2007)

FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents (August 22, 2007)

Celebrex Approved to Treat Juvenile Rheumatoid Arthritis (December 15, 2006)

FDA Approves the First Drug to Treat Irritability Associated with Autism, Risperdal
(October 6, 2006)

FDA Announces Renowned Pediatric Ethicist Robert M. Nelson, M.D., to Join Office of Pediatric Therapeutics (September 14, 2006)

FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older--Prescription Remains Required for Those 17 and Under (August 24, 2006)

FDA Warns Consumers Not to Use Triaminic Vapor Patch (June 19, 2006)

FDA Announces New Prescription Drug Information Format to Improve Patient Safety (January 18, 2006)

FDA Issues Advice to Make Earliest Stages of Drug Development More Efficient (January 12, 2006)


Public Health Advisories:

Use of Codeine by Some Breastfeeding Mothers May Lead to Life-Threatening Side Effects In Nursing Babies (August 17, 2007)

Nonprescription Cough and Cold Medicine Use in Children (August 15, 2007)

 

 

FDA Office of Pediatric Therapeutics

(Visit this site for summaries of pediatrics study reviews and the latest pediatric exclusivity
labeling changes)


<FDA News Archive>





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