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Product: 4-methylpyrazole (trade name Antizole); Fomepizole
Indication: Ethylene Glycol and Methanol Poisoning
Approval Date: 04-Dec-97
Institution: Orphan Medical, Inc.
Investigator: Dayton T Reardan, Ph.D.
Product: 5-Azacytidine
Indication: Myelodysplastic syndrome
Approval Date: 19-May-04
Institution: Mount Sinai School of Medicine
Investigator: Lewis Silverman, M.D.
Product: Actimmune and calcitrol
Indication: Osteopetrosis
Approval Date: 10-Feb-00
Institution: Medical University of South Carolina
Investigator: Lyndon Key, M.D.
Product: Alpha-Galactosidase-A
Indication: Fabry Disease
Approval Date: 24-Apr-03
Institution: Mount Sinai School of Medicine
Investigator: Robert J Desnick, M.D., Ph.D.
Product: Anti-TNF (cA2) (trade name Remicade)
Indication: Severe Crohns Disease
Approval Date: 24-Aug-98
Institution: Centocor, Inc.
Investigator: Richard V McCloskey, M.D.
Product: Auditory Brainstem Implant
Indication: Bilateral deafness secondary to surgery associated with neurofibromatosis
type II
Approval Date: 24-Oct-00
Institution: Cochlear Corporation
Investigator: Steven J Staller, Ph.D.
Product: Baclofen Intrathecal (trade name Lioresal)
Indication: Severe Spasticity
Approval Date: 25-Jun-92
Institution: Rush-Presbyterian-St. Lukes' Medical Center
Investigator: Richard D Penn, M.D.
Product: Betaine (trade name Cystadane)
Indication: Homocystinuria
Approval Date: 20-Oct-96
Institution: University of Virginia
Investigator: William G Wilson, M.D.
Product: Botulinum immune globulin injection
Indication: Infant botulism
Approval Date: 23-Oct-03
Institution: California Department of Health Services
Investigator: Stephen S Arnon, M.D.
Product: Busulfan IV
Indication: Bone Marrow Ablation
Approval Date: 04-Feb-99
Institution: UT MD Anderson Cancer Center
Investigator: Borge S Andersson, M.D., Ph.D.
Product: Cladribine (trade name Leustatin)
Indication: Mycosis fungoides and hairy cell leukemia
Approval Date: 01-Mar-
Institution: Scripps Research Institute
Investigator: Ernest Beutler, M.D.
Product: Clonidine (trade name Duraclon)
Indication: Intractable pain in cancer patients and post-op pain
Approval Date: 02-Oct-96
Institution: Wake Forest University
Investigator: James C Eisenach, M.D.
Product: CroFab
Indication: Crotalid snake bites
Approval Date: 02-Oct-00
Institution: Therapeutic Antibodies, Inc.
Investigator: Richard C Dart, M.D., Ph.D.
Product: Cysteamine
Indication: Nephropathic cystinosis
Approval Date: 15-Aug-94
Institution: University of California
Investigator: Jerry A Schneider, M.D.
Product: Cysteamine (trade name Cystagon)
Indication: Nephropathic Cystinosis
Approval Date: 15-Aug-94
Institution: University of California, San Diego
Investigator: Jerry A Schneider, M.D.
Product: Deep Brain Stimulation
Indication: Dystonia
Approval Date: 15-Apr-03
Institution: Mount Sinai Medical Center
Investigator: Mitchell F Brin, M.D.
Product: Gamma-hydroxybutyrate
Indication: Narcolepsy
Approval Date: 17-Jul-02
Institution: University of Arkansas for Medical Sciences
Investigator: Lawrence Scrima, Ph.D.
Product: Ganciclovir Intravitreal (trade name Vitrasert)
Indication: CMV Retinitis
Approval Date: 04-Mar-
Institution: University of Kentucky Research Foundation
Investigator: Thomas J Smith, M.D.
Product: Glatiramer acetate (trade name Copaxone)
Indication: Relapsing remitting multiple sclerosis
Approval Date: 20-Dec-96
Institution: Lemmon Company
Investigator: Yafith Stark, Ph.D.
Product: Histrelin Acetate (trade name Supprelin)
Indication: Central precocious puberty
Approval Date: 24-Dec-91
Institution: Massachusetts General Hospital
Investigator: Paul A Boepple, M.D.
Product: In-Exsufflator (trade name Cofflator)
Indication: Assist Ventilator dependent patients
Approval Date: 01-Feb-93
Institution: University of Medicine and Dentistry of New Jersey
Investigator: John R Bach, M.D.
Product: infusional arsenic trioxide
Indication: Acute Promyelocytic Leukemia
Approval Date: 25-Sep-00
Institution: Washington University
Investigator: John F DiPersio, M.D. Ph.D.
Product: Iobenguane sulfate I-131
Indication: Localization of Pheochromocytoma
Approval Date: 24-Mar-
Institution: University of Michigan
Investigator: Brahm Shapiro, M.D.
Product: Levocarnitine (trade name Carnitor)
Indication: Primary and Secondary Carnitine Deficiency of Genetic Origin
Approval Date: 16-Dec-92
Institution: Duke University
Investigator: Charles R Roe, M.D.
Product: Nafarelin Acetate Intranasal (trade name Synarel)
Indication: Central Precocious Puberty
Approval Date: 06-Feb-92
Institution: Baylor College of Medicine
Investigator: John L Kirkland, M.D.
Product: Neurostimulator implantable electrodes
Indication: Quadra-paraplegia with loss of hand function
Approval Date: 18-Aug-97
Institution: Case Western Reserve University
Investigator: Paul H Peckham, Ph.D.
Product: NTBC
Indication: Tyrosinemia-I
Approval Date: 18-Jan-02
Institution: University of Washington
Investigator: Ronald C Scott, M.D.
Product: Parathyroid hormone
Indication: Osteoporosis in men
Approval Date: 26-Nov-
Institution: Columbia University
Investigator: John P Bilezikian, M.D.
Product: Pegademase (trade name Adagen)
Indication: ADA replacement in Severe Combined Immunogenicity Disease
Approval Date: 21-Mar-
Institution: Enron
Investigator: Abraham Abuchowski, M.D.
Product: Pulmonary angioscope
Indication: Visualization of pulmonary emboli
Approval Date: 31-Jan-89
Institution: Regents of the University of California
Investigator: Deborah Shure, M.D.
Product: Recombinant Human Keratinocyte Growth Factor
Indication: Transplants
Approval Date: 27-May-99
Institution: University of Michigan
Investigator: James Ferrara, M.D.
Product: Sodium phenylbutyrate
Indication: Urea cycle disorders
Approval Date: 30-Apr-96
Institution: Johns Hopkins University
Investigator: Saul W Brusilow, M.D.
Product: Sodium phenylbutyrate (trade name Buphenyl)
Indication: Urea cycle disorders
Approval Date: 30-Apr-96
Institution: Ucycld Pharma
Investigator: Norbert L Wiech, Ph.D.
Product: Succimer (trade name Chemet)
Indication: Lead Poisoning in Children
Approval Date: 30-Jan-91
Institution: The Kennedy Institute
Investigator: J. Julian Chisolm, M.D.
Product: Sucrase enzyme
Indication: Sucrase-isomaltase deficiency
Approval Date: 09-Apr-98
Institution: Hartford Hospital
Investigator: Jeffrey Hyams, M.D.
Product: Tinidazole Tablets
Indication: BA/BE Study for Giardiasis
Approval Date: 17-May-04
Institution: Presutti Laboratories
Investigator: John E Presutti, B.S.
Product: Titanium expandable rib prothesis
Indication: Thoracic insufficiency syndrome
Approval Date: 24-Aug-04
Institution: University of Texas Health Science Center
Investigator: Robert M Campbell, Jr., M.D.
Product: Tobramycin for inhalation (trade name Tobi)
Indication: CF Patients with Pseudomonas Aurginosa
Approval Date: 22-Dec-97
Institution: Pathogenesis Corporation
Investigator: Alan B Montgomery, M.D.
Product: Tretinoin (trade name Vesanoid )
Indication: Acute Promyelocytic Leukemia
Approval Date: 22-Nov-
Institution: Memorial Hospital for Cancer and Allied
Investigator: Raymond P Warrell, Jr., M.D.
Product: Zinc Acetate (trade name Galzin)
Indication: Wilson's Disease
Approval Date: 28-Jan-97
Institution: University of Michigan
Investigator: George J Brewer, M.D.