List of Orphan Products Designated for the Month of March 2008 YTD 2008
Total Number of Active Designations
Generic Name:
18
Effective:
4/14/2008
Indication Designation:
Treatment of chronic graft versus host disease
Trade Name (if present): Theralux photodynamic therapy Date Designated 4/3/2008
Date Approved
Sponsor Contact Information
Kiadis Pharma Canada, Inc. 2525 Marie Curie Montreal (Quebec) H4S 2E1 CANADA
Generic Name: (3-[5-(2fluorophenyl)-1,2,4-oxadiazol-3-yl]benzoic acid) Trade Name (if present):
Indication Designation:
Treatment of spinal muscular atrophy.
Sponsor Contact Information
Date Designated 3/10/2008 Date Approved PTC Therapeutics, Inc. 100 Corporate Court South Plainfield NJ 07080
Generic Name: 11-(2-Pyrrolidin-1-yl-ethoxy)-14,19-dioxa5,7,26-triazatetracyclo[19.3.1.12,6.18,12}heptacosa1(25),2(26),3,5,8,10,12(27),16,21,23-decaene Trade Name (if present):
Indication Designation:
For treatment of myeloproliferative disorders (MPD) with the JAK2 V617F mutation.
Sponsor Contact Information
Date Designated 3/13/2008 Date Approved S*BIO Pte., Ltd. 1 Science Park Road Singapore Science Park II SINGAPORE
Generic Name: 5-[(E)-2-(4-hydroxyphenyl)-ethenyl] benzene-1,3 diol Trade Name (if present): Resveratrol Date Designated 3/13/2008
Date Approved
Indication Designation:
Treatment of MELAS syndrome
Sponsor Contact Information
Sirtris Pharmaceuticals, Inc. 200 Technology Square Cambridge MA 02139
Generic Name: 6 alpha-ethylchenodeoxycholic acid Trade Name (if present):
Indication Designation:
Treatment of primary biliary cirrhosis
Sponsor Contact Information
Date Designated 4/9/2008 Date Approved Intercept Pharmaceuticals, Inc. 18 Desbrosses Street New York NY 10013
Generic Name: 6-alpha-ethylchenodeoxycholic acid Trade Name (if present):
Indication Designation:
Treatment of primary sclerosing cholangitis
Sponsor Contact Information
Date Designated 4/9/2008 Date Approved Intercept Pharmaceuticals, Inc. 18 Desbrosses Street New York NY 10013
Generic Name: Alpha1-antitrypsin(human) Trade Name (if present):
Indication Designation:
Treatment of bronchiectasis
Sponsor Contact Information
Date Designated 4/3/2008 Date Approved Kamada, Ltd. 7 Sapir Street Ness Ziona ISRAEL
Generic Name: amrubicin Trade Name (if present):
Indication Designation:
Treatment of small cell lung cancer
Sponsor Contact Information
Date Designated 3/10/2008 Date Approved Pharmion Corporation 2525 28th Street Boulder CO 80301
Generic Name: Anti-von Willebrand Aptamer Trade Name (if present):
Indication Designation:
Treatment of thrombotic thrombocytopenic purpura
Sponsor Contact Information
Date Designated 4/9/2008 Date Approved Archemix Corporation 300 Third Street Cambridge MA 02142
Generic Name: bifidobacterium infantis 35624 Trade Name (if present):
Indication Designation:
Treatment of pediatric ulcerative colitis.
Sponsor Contact Information
Date Designated 3/24/2008 Date Approved Alimentary Health Limited Cork Airport Business Park, Building 2800 Cork IRELAND
Generic Name: cyclosporine A Trade Name (if present): NOVA22007 Date Designated 4/9/2008
Date Approved
Indication Designation:
Treatment of herpes simplex virus stromal keratitis
Sponsor Contact Information
Novagali Pharma S.A. 1 rue Pierre Fontaine 91058 Evry cedex FRANCE
Generic Name: hepatitis B immune globulin (human) Trade Name (if present): HepaGam Date Designated 3/24/2008 Date Approved 4/6/2007
Indication Designation:
Prevention of hepatitis B recurrence following orthotopic liver transplant
Sponsor Contact Information
Cangene Corporation 155 Innovation Drive
CANADA
Generic Name: Human autologous bone-forming cell derived from bone marrow stem cells Trade Name (if present):
Indication Designation:
Treatment of osteonecrosis
Sponsor Contact Information
Date Designated 3/24/2008 Date Approved Bone Therapeutics S.A. 8, rue Adrienne Bolland
BELGIUM
Generic Name: Human fibrinogen concentrate, pasteurized Trade Name (if present):
Indication Designation:
Treatment of fibrinogen deficient patients
Sponsor Contact Information
Date Designated 3/13/2008 Date Approved CSL Behring, LLC 1020 First Avenue King of Prussia PA 19406
Generic Name: milatuzumab Trade Name (if present):
Indication Designation:
Treatment of multiple myeloma
Sponsor Contact Information
Date Designated 3/10/2008 Date Approved Immunomedics, Inc. 300 American Road Morris Plains NJ 07950
Generic Name: peginterferon alfa-2b Trade Name (if present): PegIntron Date Designated 4/9/2008
Date Approved
Indication Designation:
Treatment of malignant melanoma stages IIb through IV.
Sponsor Contact Information
Schering-Plough Corporation 2000 Galloping Hill Road Kenilworth NJ 07933-0530
Generic Name: Sodium nitrite and sodium thiosulfate Trade Name (if present): Cyanide Antidote Kit Date Designated 4/9/2008
Date Approved
Indication Designation:
Treatment of known or suspected cyanide poisoning
Sponsor Contact Information
Hope Pharmaceuticals 8260 E. Gelding Drive Scottsdale AZ 85260
Generic Name: talampanel Trade Name (if present):
Indication Designation:
Treatment of amyotrophic lateral sclerosis
Sponsor Contact Information
Date Designated 3/24/2008 Date Approved TEVA Neuroscience P. O. Box 1005 Horsham PA 19044-8005