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U.S. Department of Health and Human Services

Drugs

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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.