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The Orphan Drug Act defines an orphan drug as a drug or biological product for the diagnosis, treatment, or prevention of a rare disease or condition. A rare disease is one that affects up to 200,000 people in the US or one that affects greater than 200,000 people but for which there is no reasonable expectation that the cost of developing the drug and making it available will be recovered from sales of that drug in the US.

The FDA Office of Orphan Products Development (OOPD) provides an information package that includes an overview of the FDA’s orphan drug program, a brief description of the orphan products grant program, and a current list of designated orphan products. OOPD’s information package also contains a directory sheet listing sources of information about the treatment of rare diseases, patient organizations, and availability of orphan drugs. Requests for the Rare Disease Information Directory or the entire orphan drugs information package may be made by contacting OOPD:

• Office of Orphan Products Development (HF-35)
• Food and Drug Administration
• 5600 Fishers Lane
• Rockville, MD 20857
• (301) 827-3666 or (800) 300-7469; fax: (301) 443-4915
• Internet: http://www.fda.gov/orphan/

Those agents that have been approved for marketing or whose specific indication has been approved for marketing are denoted with the footnote 1.

Orphan Drugs

Drug (Trade name); Proposed use; Sponsor

1,5-(Butylimino)-1,5 dideoxy,D-glucitol; Fabry’s disease; Gaucher’s disease; Oxford GlycoSciences

1-(11-dodecylamino-10-hydroxyundecyl)-3-7-dimethylxanthine hydrogen methanesulfonate; Hormone refractory prostate carcinoma; Cell Therapeutics

¹¹¹Indium pentetreotide (SomatoTher); Somatostatin receptor positive neuroendocrine tumors; Louisiana State Univ Medical Center Foundation

15AU81 (Remodulin); Pulmonary arterial hypertension; United Therapeutics

166Ho-DOTMP; Multiple myeloma; NeoRx

2’-deoxycytidine; Host-protective agent in acute myelogenous leukemia; Steven Grant, MD

2-0-desulfated heparin (Aeropin); Cystic fibrosis; Kennedy & Hoidal, MDs

24,25 dihydroxy-cholecalciferol; Uremic osteodystrophy; Lemmon

2-chloroethyl-3-sarcosinamide-1-nitrosourea (Sarmustine); Malignant glioma; Pangene Lawrence Panasci, MD

2-methoxyestradiol (Panzem); Multiple myeloma; EntreMed

3-(3,5-dimethyl-1H-2ylmethylene)-1,3-dihydro-indol-2-one; Kaposi’s sarcoma; von Hippel-Lindau disease; Sugen

3,4-diaminopyridine; Lambert-Eaton myasthenic syndrome; Jacobus Pharm

3-(4’aminoisoindoline-1’-one)-1-piperidine-2,6-dione (Revimid [proposed]); Multiple myeloma; Celgene

3,5,3’-triiodothyroacetate; Well-differentiated papillary, follicular, or combined papillary/follicular carcinomas of the thyroid gland; Elliot Danforth Jr, MD

4-aminosalicylic acid (Pamisyl) (Rezipas); Mild to moderate ulcerative colitis in patients intolerant to sulfasalazine; Warren Beeken, MD Parke-Davis Squibb

40SD02; Chronic iron overload resulting from conventional transfusional treatment of β-thalassemia major and sickle cell anemia; Biomedical Frontiers

5,6-dihydro-5-azacytidine; Malignant mesothelioma; ILEX Oncology

5-aza-2’-deoxycytidine; Acute leukemia; SuperGen

506U78; Chronic lymphocytic leukemia; GlaxoWellcome

6-hydroxymethylacylfulvene; Histologically confirmed advanced or metastatic pancreatic cancer; ovarian cancer; renal cellcarcinoma; MGI Pharma

8-Cyclopentyl 1,3-dipropylxanthine; Cystic fibrosis; SciClone Pharm

8-methoxsalen (Uvadex); In conjunction with the UVAR photopheresis system to treat diffuse systemic sclerosis; prevention of acute rejection of cardiac allografts; Therakos

9-cis retinoic acid (Panretin); Treatment of acute promyelocytic leukemia; Ligand Pharm

9-nitro-20-(S)-camptothecin (Camvirex); Pancreatic cancer; pediatric HIV infection/AIDS; Stehlin Foundation for Cancer Research NovoMed

Abetimus; Lupus nephritis; La Jolla Pharm

Acetylcysteine (Acetadote)(Mucomyst/Mucomyst 10 IV); IV treatment for moderate to severe acetaminophen overdose; Cumberland Bristol-Myers Squibb

Aconiazide; Tuberculosis; Lincoln Diagnostics

Adeno-associated viral-based vector cystic fibrosis gene therapy; Cystic fibrosis; Targeted Genetics

Adeno-associated viral vector containing the gene for human coagulation Factor IX (Coagulin-B); Intrahepatic and IM treatment of moderate to severe hemophilia; Avigen

Adenovirus-based vector Factor VIII complementary DNA to somatic cells (MiniAdFVIII); Hemophilia A; GenStar Therapeutics

Adenovirus-mediated herpes simplex virus-thymidine kinase gene; With gancyclovir in the treatment of malignant glioma; Ark Therapeutics Ltd.

Albendazole (Albenza); Hydatid disease (cystic echinococcosis caused by E. granulosus larvae or alveolar echinococcos is caused by E. multilocularis larvae;¹ neurocysticercosis caused by Taenia solium as: 1) Chemotherapy of parenchymal, subarachnoidal, and racemose (cysts in spinal fluid) neurocysticercosis in symptomatic cases and 2) prophylaxis of epilepsy and other sequelae in asymptomatic neurocysticercosis¹; SmithKline Beecham

Aldesleukin (Proleukin); Metastatic renal cell carcinoma;¹ metastatic melanoma;¹ primary immunodeficiency disease associated with T-cell defects; acute myelogenous leukemia; non-Hodgkin’s lymphoma; Chiron

Alemtuzumab (Campath); Chronic lymphocytic leukemia¹; Millennium and ILEX Partners, LP

Alendronate disodium (Fosamax); Bone manifestations of Gaucher’s disease; Richard J. Wenstrup, MD

Alglucerase injection (Ceredase); Replacement therapy in Gaucher’s disease type I,¹ II, and III; Genzyme

Alitretinoin (Panretin); Topical treatment of cutaneous lesions in AIDS-related Kaposi’s sarcoma¹; Ligand Pharm

Allogeneic human retinal pigment epithelial cells on gelatin microcarriers (Spheramine); Hoehn and Yahr stage 3 and 4 Parkinson’s disease; Titan Pharm

Allogeneic peripheral blood mononuclear cells (sensitized against patient alloantigens by mixed lymphocyte culture) (CYTOIMPLANT); Pancreatic cancer; Applied Immunotherapeutics, LLC

Allopurinol sodium (Zyloprim for injection); Management of patients with leukemia, lymphoma, and solid tumor malignancies who are receiving cancer therapy that causes elevations of serum and urinary uric acid levels and who cannot tolerate oral therapy¹; Catalytica Pharm

Alpha₁-proteinase inhibitor (human); Slowing the progression of emphysema in alpha₁-antitrypsin deficient patients; Aventis Behring LLC

(Prolastin); Replacement therapy in the alpha₁-proteinase inhibitor congenital deficiency state¹; Bayer

Alpha-galactosidase A (Fabrase)(CC-Galactosidase)(Replagal); Long-term enzyme replacement therapy for treatment of alpha-galactosidase A deficiency (Fabry’s disease); Robert J. Desnick, MDOrphan MedicalTranskaryotic Therapies

Alpha-melanocyte stimulatinghormone; Prevention and treatment of intrinsic acute renal failure caused by ischemia; National Institute of Diabetes, and Digestive and Kidney Diseases

Alronidase (Aldurazyme); Mucopolysaccharidosis I; BioMarin Pharm

Altretamine (Hexalen); Advanced ovarian adenocarcinoma¹; Medimmune Oncology

Amifostine (Ethyol); Reduction of the incidence of moderate to severe xerostomia in postoperative radiation treatment for head and neck cancer;¹ reduction of the incidence and severity of toxicities associated with cisplatin administration; myelodysplastic syndromes; chemoprotective agent for the following: cisplatin in metastatic melanoma, cisplatin in advanced ovarian carcinoma,¹ cyclophosphamide in advanced ovarian carcinoma; MedImmune Oncology

Aminocaproic acid (Caprogel); Topical treatment of traumatic hyphema of the eye; Eastern Virginia Medical School/Dept. of Ophthalmology

Aminosalicylic acid (Paser Granules); Tuberculosis infections¹; Jacobus Pharm Aminosidine; (Gabbromicina); Tuberculosis; Mycobacterium avium complex; Thomas P. Kanyok, PharmD

(Paromomycin); Visceral leishmaniasis (kala-azar); Thomas P. Kanyok, PharmD

Amiodarone (Amio-Aqueous); Incessant ventricular tachycardia; Wyeth Ayerst Research Labs

Amiodarone HCl (Cordarone); Acute treatment and prophylaxis of life-threatening ventricular tachycardia or ventricularfibrillation¹; Wyeth-Ayerst

Ammonium tetrathiomolybdate; Wilson’s disease; George J. Brewer, MD

Amphotericin B lipid complex (Abelcet); Invasive fungal infections¹; Liposome Co

Anagrelide (Agrylin); Polycythemia vera; essential thrombocythemia;¹ thrombocytosis in chronic myelogenousleukemia; Roberts Pharm

Ananain, comosain (Vianain); For enzymatic debridement of severe burns; Genzyme

Ancestim (Stemgen); With filgrastim to decrease the number of phereses required to collect peripheral blood progenitor cells capable of providing rapid multi-lineage hematopoietic reconstitution following myelosuppressive or myeloablative therapy; Amgen

Ancrod (Viprinex); To establish and maintain anticoagulation in heparin-intolerant patients undergoing cardiopulmonary bypass; Knoll Pharm

Angiotensin 1-7 (MARstem); Neutropenia associated with autologous bone marrow transplantation; myelodysplastic syndrome; Maret Pharm

Antiepilepsirine; Drug-resistant generalized tonic-clonic epilepsy in children and adults; Children’s Hospital, Columbus, OH

Antihemophilic factor (human) (Alphanate); von Willebrand’s disease; Alpha Therapeutic

Antihemophilic factor (recombinant) (ReFacto); Control/Prevention of hemorrhagic episodes and for surgical prophylaxis in patients with hemophilia A¹; Genetics Institute

Antihemophilic factor (recombinant) (Kogenate); Prophylaxis/Treatment of bleeding in hemophilia A¹ and for prophylaxis when surgery is required in these patients¹; Bayer

Antihemophilic factor/von Willebrand factor complex (human), dried,pasteurized (Humate-P); Treatment/Prevention of bleeding in hemophilia A (classical hemophilia) in adult patients and treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease, and in mild to moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate in adult and pediatric patients¹; Aventis Behring LLC

Antithrombin III (human)

(ATnativ); Hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or thromboembolism¹; Pharmacia & Upjohn AB

(Thrombate III); Replacement therapy in congenital deficiency of AT-III to prevent and treat thrombosis and pulmonary emboli¹; Bayer

(Antithrombin III human); To prevent/arrest episodes of thrombosis in patients with congenital AT-III deficiency or to prevent the occurrence of thrombosis in patients with AT-III deficiency who have undergone trauma or who are about to undergo surgery or parturition; American National Red Cross

Antithrombin III (human) concentrate IV (Kybernin P); Prophylaxis/Treatment of thromboembolic episodes in genetic AT-III deficiency; Aventis Behring LLC

Anti-thymocyte globulin (Rabbit) (Thymoglobulin); Myelodysplastic syndrome (MDS); SangStat Medical

Anti-thymocyte serum (Nashville Rabbit Anti-thymocyteSerum); Allograft rejection, including solid organ (kidney, liver, heart, lung, pancreas) and bone marrow transplantation; Applied Medical Research

Antivenin crotalidae polyvalent immune Fab (ovine)(CroFab); Treatment of envenomations inflicted by North American crotalid snakes¹; Protherics

Antivenom (crotalidae) purified(avian); Treatment of envenomation by poisonous snakes belonging to the Crotalidae family; Ophidian

AP1903; Acute graft-vs-host disease in patients undergoing bone marrow transplantation; Ariad Gene Therapeutics

APL 400-020 V-Beta DNA vaccine; Cutaneous T-cell lymphoma; Wyeth-Lederle Vaccines & Pediatrics

Apomorphine; Treatment of the on-off fluctuations associated with late-stage Parkinson’s disease; Pentech Pharm

Apomorphine HCl; Treatment of the on-off fluctuations associated with late-stage Parkinson’s disease; Mylan

Aprotinin (Trasylol); Prophylaxis to reduce perioperative blood loss and the homologous blood transfusion requirement in patients undergoing cardiopulmonary bypass surgery in the course of repeat coronary artery bypass graft (CABG) surgery, and in selected cases of primary CABG surgery when the risk of bleeding is especially high (impaired hemostasis), or where transfusion is unavailable or unacceptable¹; Bayer

Arcitumomab (99m Tc-labeled CEA-Scan); Diagnosis and localization of primary, residual, recurrent, and metastatic medullary thyroidcarcinoma; Immunomedics

Arginine butyrate; Beta-hemoglobinopathies and beta-thalassemia; Susan P. Perrine, MD

Arsenic trioxide (Trisenox); Acute promyelocytic leukemia;¹ chronic myeloid leukemia; multiple myeloma; myelodysplastic syndrome;¹ acute myelocytic leukemia subtypes M0, M1, M2, M4, M5, M6, and M7; Cell Therapeutics

Artesunate; Malaria; World Health Organization

Atovaquone (Mepron); AIDS-associated Pneumocystis carinii pneumonia (PCP);¹ prevention of PCP in high-risk, HIV-infected patients (defined by ³ 1 episode of PCP or a peripheral CD4+ (T4 helper/inducer) lymphocyte count £ 200/mm³);¹ treatment/suppression of Toxoplasma gondii encephalitis; primary prophylaxis of HIV-infected people at high risk for developing T. gondii encephalitis; GlaxoWellcome GlaxoWellcome Res & Devel

Augmerosen (Genasense); Multiple myeloma; acute myelocytic leukemia; chronic lymphocytic leukemia; Genta

Autologous DNP-conjugated tumor vaccine (M-Vax); Adjuvant therapy in melanoma patients with surgically resectable lymph node metastasis (Stage III and limited Stage IV disease); Avax Technologies

Autolymphocyte therapy; Renal cell carcinoma; Cytogen

Azacitadine; Myelodysplastic syndromes; Pharmion

Azathioprine (Imuran); Oral manifestations of graft-vs-host disease; Oral Solutions

B lymphocyte stimulator (BLyS); Common variable immunodeficiency (CVID); Human Genome Sciences

Bacitracin (Altracin); Antibiotic-associated pseudomembranous enterocolitis caused by toxins A and B elaborated by Clostridium difficile; AL Labs

Baclofen (Lioresal Intrathecal); Intractable spasticity caused by multiple sclerosis or spinal cord injury; intractable spasticity caused by spinal cord injury, multiple sclerosis, and other spinal diseases (eg, spinal ischemia, spinal tumor, transverse myelitis, cervical spondylosis, degenerative myelopathy);¹ spasticity associated with cerebral palsy; Infusaid Medtronic

Basiliximab (Simulect); Prophylaxis of solid organ rejection¹; Novartis

Beclomethasone 17,21-dipropionate; To prevent GI graft-vs-host disease; Enteron Pharm

Beclomethasone dipropionate; Oral administration for intestinal graft-vs-host disease; George B. McDonald, MD

Benzoate and phenylacetate (Ucephan); Adjunctive therapy to prevent/treat hyperammonemia in patients with urea cycle enzymopathy caused bycarbamylphosphate synthetase, ornithine, transcarbamylase, or argininosuccinate synthetase deficiency¹; B Braun Medical

Benzoate/Phenylacetate (Ammonul); Acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle; Medicis Pharm

Benzophenone-3, octylmethyoxycinna-mate, avobenzone, titanium dioxide, zinc oxide (Total Block VL SPF 75); Prevent visible light-induced skin photosensitivity as a result of porfimer sodium photodynamic therapy; Fallien Cosmeceuticals Ltd.

Benzydamine HCl (Tantum); Prophylactic treatment of oral mucositis resulting from radiation therapy for head andneck cancer; Angelini Pharm

Benzylpenicillin, benzylpenicilloic, benzylpenilloic acid (Pre-Pen/MDM); To assess risk of penicillin administration when it is the preferred drug in adults who have a history of clinical penicillin sensitivity; Hollister-Stier Labs LLC

Beractant (Survanta Intratracheal Suspension); Prevention/Treatment of neonatal respiratory distress syndrome;¹ full-term newborns with respiratory failure caused by meconium aspiration syndrome, persistent pulmonary hypertension of the newborn, or pneumonia and sepsis; Ross

Beraprost; Pulmonary arterial hypertension associated with any New York Heart Association classification; United Therapeutics

Beta alethine (Betathine); Multiple myeloma; metastatic melanoma; Dovetail Tech

Betaine (Cystadane); Homocystinuria¹; Orphan Medical

Bexarotene (Targretin); Cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to ³ 1 prior systemic therapy¹; Ligand Pharm

Bindarit; Lupus nephritis; Angelini Pharm

Bis(4-fluorophenyl)phenylacetamide; Sickle cell disease; ICAgen

Bispecific antibody 520c9x22; In vivo serotherapy for ovarian cancer; Medarex

Bleomycin (Blenoxane); Pancreatic cancer; Genetronics

Bleomycin sulfate (Blenoxane); Malignant pleural effusion¹; Bristol-Myers SquibbPharm Res Inst

Bosentan (Tracleer); Pulmonary arterial hypertension¹; Actelion Life Sciences

Botulinum toxin type A; Synkinetic closure of the eyelid associated with VII cranial nerve aberrant regeneration; Botulinim Toxin Res Assoc

(Botox); Blepharospasm and strabismus associated with dystonia in adults (³ 12 years of age);¹ cervical dystonia;¹ dynamic muscle contracture in pediatric cerebral palsy; Allergan

(Dysport); Cervical dystonia; dynamic muscle contractures in pediatric cerebral palsy; essential blepharospasm; Ipsen Limited Porton International

Botulinum toxin type B (NeuroBloc); Cervical dystonia¹; Elan Pharm

Botulinum toxin type F (Dysport); Cervical dystonia; essential blepharospasm; Ipsen Limited

Botulism immune globulin; Infant botulism; CA Dept Health Services

Bovine colostrum; AIDS-related diarrhea; Donald Hastings, DVM

Bovine immunoglobulin concentrate, Cryptosporidium parvum (Sporidin-G); Treatment/Symptomatic relief of Cryptosporidium parvum infection of the GI tract in immunocompromised patients; GalaGen

Bovine whey protein concentrate (Immuno-C); Cryptosporidiosis caused by Cryptosporidium parvum in the GI tract of patients who are immunodeficient/immunocompromised or immunocompetent; Biomune Systems

Branched chain amino acids; Amyotrophic lateral sclerosis; Mount Sinai Medical Center

Brimonidine (Alphagan); Anterior ischemic optic neuropathy; Allergan

Bromhexine (Bisolvon); Mild to moderate keratoconjunctivitis sicca in Sjogren’s syndrome; Boehringer Ingelheim

Broxuridine (Broxine/Neomark); Radiation sensitizer in the treatment of primary brain tumors; NeoPharm

Bryostatin-1; With paclitaxel in the treatment of esophageal cancer; GPC Biotech

Buffered intrathecal electrolyte/dextrose injection (Elliotts B Solution); Diluent in intrathecal administration of methotrexate and cytarabine for prevention/treatment of meningeal leukemia or lymphocytic lymphoma¹; Orphan Medical

Buprenorphine HCl (Subutex); Opiate addictions in opiate users; Reckitt & Colman

Buprenorphine in combination with naloxone (Suboxone); Opiate addiction in opiate users; Reckitt & Colman

Busulfan

(Busulfex); Preparative therapy in the treatment of malignancies with bone marrow transplantation¹; Orphan Medical

(Spartaject); Preparative therapy for malignancies treated with bone marrow transplantation; primary brain malignancies; Sparta SuperGen

(Busulfan-Spartaject); Intrathecal therapy for neoplastic meningitis; SuperGen

Butyrylcholinesterase; Reduction and clearance of toxic blood levels of cocaine in overdose; postsurgical apnea; Shire Labs

BW 12C; Sickle cell disease; Burroughs Wellcome

C1 esterase inhibitor (human); Prevention/Treatment of angioedema caused by C1-esterase inhibitor deficiency; Alpha Therapeutic

C1-esterase inhibitor, human,pasteurized (Berinert P); Prevention/Treatment of acute attacks of hereditary angioedema; Aventis Behring LLC

C1-inhibitor (C1-Inhibitor [human] Vapor Heated, Immuno); Treatment of acute attacks of angioedema; prevention of acute attacks of angioedema, including short-term prophylaxis for patients requiring dental or other surgical procedures; Baxter Healthcare

Caffeine (Cafcit); Apnea of prematurity¹; OPR Development, LP

Calcitonin-human for injection (Cibacalcin); Symptomatic Paget’s disease (osteitis deformans)¹; Novartis

Calcium acetate (Phos-Lo); Hyperphosphatemia in end-stage renal failure¹/disease; Braintree Pharmedic

Calcium carbonate (R & D Calcium Carbonate/600); Hyperphosphatemia in end-stage renal disease; R & D Labs

Calcium gluconate (Calgonate); A wash for hydrofluoric acid spills on human skin; Calgonate

Calcium gluconate gel (H-F Gel); Emergency topical treatment of hydrogen fluoride (hydrofluoric acid) burns; LTR Pharm Paddock Labs

Calfactant (Infasurf); Acute respiratory distress syndrome (ARDS); ONY

Carbamic acid, [[4-[[3-[[4-[1-(4-hydroxyphenyl)-1-methyl-ethyl]phenoxyl]methyl]phenyl]methoxy]-phenyl]iminomethyl]-,ethyl ester; Management of cystic fibrosis; Boeringer Ingelheim

Carbamylglutamic acid; N-acetylglutamate synthetase deficiency; Orphan Europe

Carmustine; Intracranial malignancies; Direct Therapeutics

Cascara sagrada fluid extract; For oral drug overdosage to speed lower bowel evacuation; Intramed

CDP571; Crohn’s disease; Celltech Chiroscience Limited

Centruroides immune F(ab)2 (Alacramyn); Scorpion envenomations requiring medical attention; Silanes Labs SA de CV

Ceramide trihexosidase/alpha-galactosidase A; Fabry’s disease; Genzyme

Cetuximab; Squamous cell cancer of the head and neck in patients who express epidermal growth factor receptor; ImClone Systems

Chenodiol (Chenix); Radiolucent stones in well-opacifying gallbladders, where elective surgery would be undertaken except for presence of increased surgical risk caused bysystemic disease or age¹; Solvay

Chimeric (human-murine) G250 IgG monoclonal antibody; Renal cell carcinoma; Wilex Biotechnology GmbH

Chimeric, humanized monoclonal antibody to staphylococcus; Prophylaxis of S. epidermidis sepsis in low birth weight (£ 1500 g) infants; Biosynexus

Chlorhexidine gluconate mouth rinse (Peridex); Amelioration of oral mucositis associated with cytoreductive therapy used in conditioning patients for bone marrow transplantation therapy; Procter & Gamble

Choline chloride (Intrachol); Choline deficiency, specifically the choline deficiency, hepatic steatosis, and cholestasis associated with long-term parenteral nutrition; Orphan Medical

Chondrocyte-alginate gel suspension; To correct vesicoureteral reflux in the pediatric population; Curis

Ciliary neurotrophic factor; Amyotrophic lateral sclerosis; Regeneron Pharm

Cisplatin/Epinephrine (IntraDose); Metastatic malignant melanoma; squamous cell carcinoma of the head and neck; Matrix Pharm

Citric acid, glucono-delta-lactone, and magnesium carbonate (Renacidin Irrigation); Renal and bladder calculi of the apatite or struvite variety¹; United-Guardian

Cladribine

(Leustatin Injection); Hairy-cell leukemia;¹ chronic lymphocytic leukemia; non-Hodgkin’s lymphoma; acute myeloid leukemia; RW Johnson Pharm Res Inst

(Mylinax); Chronic progressive multiple sclerosis; RW Johnson Pharm Res Inst

Clindamycin (Cleocin); Treatment/Prevention of Pneumocystis carinii pneumonia associated with AIDS; Pharmacia & Upjohn

Clofazimine (Lamprene); Lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum¹; Novartis

Clonazepam (Klonopin); Hyperexplexia (startle disease); Hoffmann-La Roche

Clonidine (Duraclon); For continuous epidural administration as adjunctive therapy with intraspinal opiates for pain in cancer patients tolerant or unresponsive to intraspinal opiates¹; Roxane Labs

Clostridial collagenase; Advanced (involutional or residual stage) Dupuytren’s disease; L. Hurst, MD and M. Badalamente, PhD

Clotrimazole; Sickle cell disease; Carlo Brugnara, MD

Coagulation factor VIIa(recombinant) (NovoSeven); Bleeding episodes in hemophilia A or B with inhibitors to Factor VIII or Factor IX¹; Novo Nordisk Pharm

Coagulation factor IX (Mononine); Replacement treatment for/prophylaxis of hemorrhagic complications of hemophilia B¹; Armour Pharm

Coagulation factor IX (human) (AlphaNine); Replacement therapy in hemophilia B for prevention and control of bleeding episodes and during surgery to correct defective hemostasis¹; Alpha Therapeutic

Coagulation factor IX (BeneFix); Hemophilia B¹; Genetics Institute

Coenzyme Q10; Huntington’s disease; Vitaline

Colfosceril palmitate, cetyl alcohol, tyloxapol

(Exosurf Neonatal for Intratracheal Suspension); Prevention of hyaline membrane disease (respiratory distress syndrome) in infants born at£ 32 weeks gestation;¹ to treat established hyaline membrane disease at all gestational ages¹; GlaxoWellcome

(Exosurf); Adult respiratory distress syndrome (ARDS); GlaxoWellcome Res & Devel

Collagenase (lyophilized) for injection (Plaquase); Peyronie’s disease; Advance Biofactures

Conjugate of human transferrin and a mutant diphtheria toxin (CRM 107); Malignant tumors of the CNS; INTELLIgene Expressions

Corticorelin ovine triflutate (Acthrel); To differentiate between pituitary and ectopic production of ACTH in ACTH-dependent Cushing’s syndrome^1<