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  |
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.