From January 2010 to February 2012, new pediatric information was added to labeling of 62 drugs, six vaccines and six blood products. The spectrum of approved agents to treat pediatric patients continues to expand (see table below).

There are new pediatric drug therapies for

Gardasil vaccine has a new indication:

There is a new biologic:

The 12 drugs for which studies did not establish the effectiveness for use in children are noted in the table with an asterisk (*). These drugs include: Chantix for smoking cessation; Famvir for the treatment of recurrent herpes labialis; INOmax for prevention of bronchopulmonary dysplasia in preterm neonates; Kytril for prevention of postoperative nausea and vomiting; Nasonex for treatment of nasal polyps; Plavix for the reduction of the incidence of thrombosis in children with systemic to pulmonary artery shunts for palliation of cyanotic congenital heart disease; and Xolair for moderate to severe persistent asthma.


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