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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 (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 |
