Orphan Drugs: In Development

DISEASE Myelodysplastic Syndromes (continued) DRUG NAME Neupogen~ filigrastim SPONSOR FDA OFFICIAL DESIGNATION Amgen treatment of myelodysplastic (Thousand Oaks, CA) syndrome DEVELOPMENT STATUS Phase III Myoclonus L-5 hydroxytrypto- Bolar Pharmaceuticals treatment of postanoxic intention Phase II phan (L-5HTP) (Copiague, NY) myoclonus Nerve Repair leupeptin Lawrence Hurst, M.D. adjunct to microsurgical peripheral Phase I (Stony Brook, NY) nerve repair Neutropenia Leucomax~ Schering-Plough treatment of neutropenia associated Phase III granulocyte/ (Madison, NJ) with bone marrow transplants macrophage-colony stimulating factor Leucomax~ Schering-Plough treatment of AIDS patients with Phase II/III granulocyte/ (Madison, NJ) neutropenia due to either the disease macrophage-colony itself or zidovudine (azidothymidinestimulating factor AZT) or ganciclovir (DHPG) therapy Neupogen~ Amgen treatment of neutropenia associated Phase III filigrastim (Thousand Oaks, CA) with bone marrow transplants Neupogen~ Amgen treatment of patients with severe Phase III filigrastim (Thousand Oaks, CA) chronic neutropenia (absolute neutrophil count less than 500/mm) Osteomyelitis Septopal~ EM Industries treatment of chronic osteomyelitis Phase III gentamicin (Hawthorne, NY) of post-traumatic, post-operative or impregnated PMMA hematogenous origin beads on surgical wire Paget's Disease Miacalcin Nasal Sandoz treatment of symptomatic Paget's Phase III Spray (East Hanover, NJ) disease of bone (osteitis deformans) calcitonin salmon nasal spray Pain clonidine HCL Fujisawa epidural administration for the Phase III (epidural injection) (Deerfield, IL) treatment of pain in cancer patients tolerant to, or unresponsive to, intraspinal opiates Papillomavirus/ Wellferon~ Burroughs Wellcome treatment of human papillomavirus application submitted Papillomatosis interferon alfa-nl (Rsch. Triangle Park, NC) (HPV) in patients with severe resistant/recurrent respiratory (laryngeal) papillomatosis Penicillin Pre-Pen/MDM Schwarz Pharma assessing the risk of administering Phase III Sensitivity benzylpenicillin, Kremers Urban penicillin when it is the preferred benzylpenicilloic, (Milwaukee, WI) drug of choice in adult patients benzylpenilloic acid who have previously received penicillin and have a history of clinical sensitivity Pneumocystis atovaquone Burroughs Wellcome prevention of PCP in high-risk, Phase III Carinii Pneumonia (PCP) (566C80) (Rsch. Triangle Park, NC)v (Rsch. Triangle Park, NC) HIV-infected patients defined by a history of one or more episodes of PCP and/or a peripheral CD4 + (T4 helper/inducer) lymphocyte count less than or equal to 200/mm3 atovaquone Burroughs Wellcome treatment of AIDS-related PCP Phase III (566C80) (Rsch. Triangle Park, NC) Dapsone Jacobus Pharmaceutical prophylaxis for PCP Phase III (Princeton, NJ) Dapsone Jacobus Pharmaceutical treatment of PCP in combination Phase III (Princeton, NJ) with trimethoprim pentamidine Rhone-Poulenc Rorer treatment of PCP application submitted isethionate (Collegeville, PA) PneumopentM Fisons Corporation prevention of PCP in patients at application submitted pentamidine (Bedford, MA) high risk of developing this disease isethionate (inhalation) trimetrexate U.S. Bioscience treatment of PCP in AIDS patients Phase III glucuronate (West Conshohocken, PA) 12

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Title
Orphan Drugs: In Development
Author
Pharmaceutical Research and Manufacturers of America
Canvas
Page 12
Publication
Pharmaceutical Manufacturers Association.
1992
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reports
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reports

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"Orphan Drugs: In Development." In the digital collection Jon Cohen AIDS Research Collection. https://name.umdl.umich.edu/5571095.0504.010. University of Michigan Library Digital Collections. Accessed June 11, 2025.
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