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 |