Orphan Drugs Approved in 2002

Medications and treatments for rare diseases

Eight treatments received U.S. Food and Drug Administration (FDA) approval for marketing as of October 15, 2002. Each is listed below, with the date approved for marketing in the U.S., and manufacturer contact information. Internet links are provided, when available.

ibritumomab (trade name: Zevalin)
For treatment of B-cell non-Hodgkin's lymphoma
Approved for marketing: 2/19/02

IDEC Pharmaceuticals
3030 Callan Road
San Diego, CA 92121

imatinib (trade name: Gleevec )
For treatment of gastrointestinal stromal tumors (had been approved 5/01 for treatment of chronic myeloid leukemia)
Approved for marketing: 2/1/02

Novartis
One Health Plaza
East Hanover, NJ

nitisinone (trade name: Orfadin)
For treatment of tyrosinemia type I
Approved for marketing: 1/18/02

Swedish Orphan AB Drottninggatan 98
SE-111 60 Stockholm
Sweden SE

oxybate (trade name: Xyrem )
For treatment of cataplexy, a form of narcolepsy
Approved for marketing: 7/17/02

Orphan Medical, Inc.
13911 Ridgedale Drive, Suite 250
Minnetonka, MN 55305

rasburicase (trade name: Elitek)
For treatment of malignancy-associated or chemotherapy-induced hyperuricemia
Approved for marketing: 7/12/02

Sanofi-Synthelabo
9 Great Valley
Malvern, PA 19355

synthetic porcine secretin
For use in conjunction with diagnostic procedures for pancreatic disorders to increase pancreatic fluid secretion
Also approved for use in the diagnosis of gastrinoma associated with Zollinger-Ellison syndrome
Approved for marketing: 4/4/02

ChiRhoClin, Inc.
15500 Gallaudet Ave.
Silver Spring, MD

treprostinil (trade name: Remodulin)
For treatment of pulmonary arterial hypertension
Approved for marketing: 5/21/02

United Therapeutics
68 T.W. Alexander Drive
P.O. Box 14186
Research Triangle Park, NC 27709