List of all Orphan Designated Products that have received Market Approval year to date by FDADocs

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									 List of Orphan Designated Approved Products YTD 2008
 Total Number of Active Designations           12                       Effective:           4/14/2008
 Generic Name:                               Indication Designation:
 Adalimumab                                  Treatment of juvenile rheumatoid arthritis


 Trade Name (if present):
 Humira                                      Sponsor Contact Information
Date Designated 3/21/2005                    Abbott Laboratories
Date Approved    2/21/2008                   200 Abbott Park Road
                                             Abbott Park IL 60064-6157


 Generic Name:                               Indication Designation:
 Antihemophilic factor (recombinant)         For the control and prevention of hemorrhagic episodes and for surgical
                                             prophylaxis in patients with hemophilia A (congenital factor VIII deficiency
                                             or classic hemophilia).
 Trade Name (if present):
 ReFacto                                     Sponsor Contact Information
Date Designated 2/8/1996                     Wyeth Pharmaceuticals, Inc.
Date Approved     1/1/9999                   P. O. Box 8299
                                             Philadelphia PA 19101-8299


 Generic Name:                               Indication Designation:
 Bendamustine hydrochloride                  Treatment of chronic lymphocytic leukemia


 Trade Name (if present):
 Treanda                                     Sponsor Contact Information
Date Designated 8/17/2007                    Cephalon, Inc.
Date Approved    3/20/2008                   41 Moores Road
                                             Frazer PA 19355


 Generic Name:                               Indication Designation:
 Levoleucovorin                              For use in conjunction with high-dose methotrexate in the treatment of
                                             osteosarcoma.

 Trade Name (if present):
                                             Sponsor Contact Information
Date Designated 8/1/1991                     Spectrum Pharmaceuticals, Inc.
Date Approved     3/7/2008                   157 Technology Drive
                                             Irgine CA 92618


 Generic Name:                               Indication Designation:
 Potassium Iodide Oral Solution              For use as a thyroid blocking agent in pediatric patients exposed to
                                             radiactive iodine

 Trade Name (if present):
 ThyroShield                                 Sponsor Contact Information
Date Designated 11/17/2004                   Fleming & Company, Pharmaceuticals
Date Approved     1/1/9999                   1733 Gilsinn Lane
                                             Fenton MO 63026


 Generic Name:                               Indication Designation:
 Pulmonary surfactant replacement, porcine   For the treatment and prevention of respiratory distress syndrome in
                                             premature infants.

 Trade Name (if present):
 Curosurf                                    Sponsor Contact Information
Date Designated 8/2/1993                     Dey Laboratories
Date Approved     1/1/9999                   2751 Napa Valley Corporate Drive
                                             Napa CA 94558


 Generic Name:                               Indication Designation:
 Rilonacept                                  Treatment of CIAS1-Associated Periodic Syndromes


 Trade Name (if present):
 Arcalyst                                    Sponsor Contact Information
Date Designated 12/20/2004                   Regeneron Pharmaceuticals, Inc.
Date Approved    2/27/2008                   777 Old Saw Mill River Road
                                             Tarrytown NY 10591
 Generic Name:                                Indication Designation:
 Somatropin (rDNA origin)                     Treatment of idiopathic or organic growth hormone deficiency in children
                                              with growth failure.

 Trade Name (if present):
 Saizen                                       Sponsor Contact Information
Date Designated 3/6/1987                      Serono Laboratories, Inc.
Date Approved     1/1/9999                    100 Longwater Circle
                                              Norwell MA 02061


 Generic Name:                                Indication Designation:
 Somatropin (rDNA origin)                     Long-term treatment of children who have growth failure due to a lack of
                                              adequate endogenous growth hormone secretion.

 Trade Name (if present):
 Nutropin Depot                               Sponsor Contact Information
Date Designated 10/28/1999                    Genentech, Inc.
Date Approved     1/1/9999                    1 DNA Way
                                              South San Francisco CA 94080-4990


 Generic Name:                                Indication Designation:
 Somatropin (rDNA origin) injection           Treatment of growth failure in children due to inadequate growth hormone
                                              secretion.

 Trade Name (if present):
 Norditropin                                  Sponsor Contact Information
Date Designated 7/10/1987                     Novo Nordisk Pharmaceuticals
Date Approved     1/1/9999                    100 Overlook Center
                                              Suite 200
                                              Princeton NJ 08540

 Generic Name:                                Indication Designation:
 Surface active extract of saline lavage of   Treatment and prevention of respiratory failure due to pulmonary surfactant
 bovine lungs                                 deficiency in preterm infants.


 Trade Name (if present):
 Infasurf                                     Sponsor Contact Information
Date Designated 6/7/1985                      ONY, Inc.
Date Approved     1/1/9999                    1576 Sweet Home Road
                                              Amherst NY 14228


 Generic Name:                                Indication Designation:
 Vaccinia Immune Globulin (Human)             Treatment of complications of vaccinia vaccination
 Intravenous

 Trade Name (if present):
 CNJ-016                                      Sponsor Contact Information
Date Designated 6/18/2004                     Cangene Corporation
Date Approved     1/1/9999                    104 Chancellor Matheson Road
                                              Winnipeg, ManitobaR3T 5Y3

                                              CANADA

								
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