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  5. 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)
  1. Development Resources

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)

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.

As of 11/24/2009

Total Approved Active Moieties with No Marketing Protection for which FDA has Issued a Written Request = 19

Active Moiety Sponsor
Ampicillin Bristol-Myers Squibb/ Clonmel/Sandoz
Azithromycin * Pfizer
Baclofen Schwarz
Dactinomycin Merck
Daunomycin Bedford
Griseofulvin Johnson & Johnson/ Schering/Pedinol
Hydrochlorothiazide Actavis Elizabeth / Apotex / Clonmel
Hydrocortisone (Hydrocortisone Valerate) BMS
Isotretinoin New! Hoffman-La Roche, Inc./ Barr / Ranbaxy
Lindane Morton Grove
Lithium Able/Barr/Bayer
Lorazepam Baxter / Roxane / Biovail
Meropenem AstraZeneca
Methotrexate Abraxis / Barr / Bedford
Metoclopramide Schwarz
Morphine Elan/Faulding
Rifampin * Aventis
Sodium Nitroprusside Abbott
Vincristine Eli Lilly

 * Active moiety granted second request.