Approved Active Moieties That Have Appeared On The National Institutes Of Health’s (NIH) Annual Priority List For Which FDA Has Issued A Written Request For Pediatric Studies Under The Best Pharmaceuticals For Children Act (BPCA) (updated 9/18/2007)

Note:  This List identifies older approved active moieties which FDA has issued a Written Request for pediatric studies in accordance with the Best Pharmaceuticals for Children Act.  In addition, this page lists only innovators or reference listed holder to which FDA has issued a Written Request.  For complete List of all approved application holders, please see the Orange Book.

Total Approved Active Moieties with No Marketing Protection for which FDA has Issued a Written Request = 20

 * Active moiety granted second request.