Pediatric Exclusivity Labeling Changes
as of May 19, 2008
Note: Each label listed on this page reflects the pediatric changes for studies submitted in response to a Written Request and is not necessarily the most current label. Jump to New listings.
1. 7/1/1998
(4/15/1999) Ibuprofen - Motrin (McNeil)
Label Fever, minor aches & pain, cold symptoms Extended age range from 2 years to 6 months for the over-the-counter use based on a large safety database (27,000 patients)
2. 7/1/1998
(1/12/1999) Ibuprofen - Advil (Whitehall)
Label Fever, minor aches & pain, cold symptoms Extended age range from 2 years to 6 months for the over-the-counter use based on a large safety database (14,291 patients)
3. 9/18/1998
(10/15/1998) Midazolam - Versed (Roche)
Label Pediatric Formulation Sedation/anxiolysis/amnesia Specified the effective dose, effective dose range, and time of onset Defined volume of distribution and similarity to adult protein binding and elimination
Additional information on AE's and warnings about concomitant medications
Identified a subpopulation (children with congenital heart disease and pulmonary hypertension) at higher risk for AE's and the need to start therapy at the lower end of the dosing range
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