List of Orphan Products Receiving Marketing Approval in March 2008
Total Number of Active Designations
Generic Name: Antihemophilic factor (recombinant) Trade Name (if present): ReFacto Date Designated 2/8/1996 Date Approved 1/1/9999
11
Effective:
4/14/2008
Indication Designation:
For the control and prevention of hemorrhagic episodes and for surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia).
Sponsor Contact Information
Wyeth Pharmaceuticals, Inc. P. O. Box 8299 Philadelphia PA 19101-8299
Generic Name: Bendamustine hydrochloride Trade Name (if present): Treanda Date Designated 8/17/2007 Date Approved 3/20/2008
Indication Designation:
Treatment of chronic lymphocytic leukemia
Sponsor Contact Information
Cephalon, Inc. 41 Moores Road Frazer PA 19355
Generic Name: Levoleucovorin Trade Name (if present):
Indication Designation:
For use in conjunction with high-dose methotrexate in the treatment of osteosarcoma.
Sponsor Contact Information
Date Designated 8/1/1991 Date Approved 3/7/2008 Spectrum Pharmaceuticals, Inc. 157 Technology Drive Irgine CA 92618
Generic Name: Potassium Iodide Oral Solution Trade Name (if present): ThyroShield Date Designated 11/17/2004 Date Approved 1/1/9999
Indication Designation:
For use as a thyroid blocking agent in pediatric patients exposed to radiactive iodine
Sponsor Contact Information
Fleming & Company, Pharmaceuticals 1733 Gilsinn Lane Fenton MO 63026
Generic Name: Pulmonary surfactant replacement, porcine Trade Name (if present): Curosurf Date Designated 8/2/1993 Date Approved 1/1/9999
Indication Designation:
For the treatment and prevention of respiratory distress syndrome in premature infants.
Sponsor Contact Information
Dey Laboratories 2751 Napa Valley Corporate Drive Napa CA 94558
Generic Name: Somatropin (rDNA origin) Trade Name (if present): Saizen Date Designated 3/6/1987 Date Approved 1/1/9999
Indication Designation:
Treatment of idiopathic or organic growth hormone deficiency in children with growth failure.
Sponsor Contact Information
Serono Laboratories, Inc. 100 Longwater Circle Norwell MA 02061
Generic Name: Somatropin (rDNA origin) Trade Name (if present): Nutropin Depot Date Designated 10/28/1999 Date Approved 1/1/9999
Indication Designation:
Long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion.
Sponsor Contact Information
Genentech, Inc. 1 DNA Way South San Francisco CA 94080-4990
Generic Name: Somatropin (rDNA origin) injection Trade Name (if present): Norditropin Date Designated 7/10/1987 Date Approved 1/1/9999
Indication Designation:
Treatment of growth failure in children due to inadequate growth hormone secretion.
Sponsor Contact Information
Novo Nordisk Pharmaceuticals 100 Overlook Center Suite 200 Princeton NJ 08540
Generic Name: Sorafenib Trade Name (if present): Nexavar Date Designated 4/20/2006 Date Approved 3/24/2008
Indication Designation:
Treatment of hepatocellular carcinoma
Sponsor Contact Information
Bayer Pharmaceuticals Corporation 400 Morgan Lane West Haven CT 06516
Generic Name: Surface active extract of saline lavage of bovine lungs Trade Name (if present): Infasurf Date Designated 6/7/1985 Date Approved 1/1/9999
Indication Designation:
Treatment and prevention of respiratory failure due to pulmonary surfactant deficiency in preterm infants.
Sponsor Contact Information
ONY, Inc. 1576 Sweet Home Road Amherst NY 14228
Generic Name: Vaccinia Immune Globulin (Human) Intravenous Trade Name (if present): CNJ-016 Date Designated 6/18/2004 Date Approved 1/1/9999
Indication Designation:
Treatment of complications of vaccinia vaccination
Sponsor Contact Information
Cangene Corporation 104 Chancellor Matheson Road Winnipeg, ManitobaR3T 5Y3 CANADA