 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)
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