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 (http://www.fda.gov/cder/ob/default.htm).
Total Approved Active Moieties with No Marketing Protection for which FDA has Issued a Written Request = 20
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 |
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.
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Date created: October 31, 2003; Last updated: September 18, 2007 |