FDA-Approved Treatments

Drugs with orphan designation or indications for rare diseases — 955 total

Treatment data is sourced from FDA drug labels, DailyMed, and openFDA.
Report missing data
💊

Drug information is sourced from FDA labels and prescribing information. Always verify current prescribing information with your pharmacist or prescriber before starting, stopping, or changing any medication.

Orphan

Renacidin Irrigation

Citric acid, glucono-delta-lactone and magnesium carbonate

United-Guardian, Inc.

Upper tract urothelial carcinoma
View details →
Orphan⚠️ Black Box

Leustatin Injection

Cladribine

R. W. Johnson Pharmaceutical Research Institute

1 INDICATIONS AND USAGE Cladribine tablets are indicated for the treatment of relapsing form of multiple sclerosis (MS), to include relapsing-remittin

Classic hairy cell leukemiaView details →

CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE

Rising Pharma Holdings, Inc.

INDICATIONS AND USAGE Clindamycin phosphate topical lotion is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloo

Pemphigus vulgaris
View details →
Orphan⚠️ Black Box

Onfi

clobazam

Lundbeck, Inc.

1 INDICATIONS AND USAGE ONFI ® (clobazam) is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patie

Lennox-Gastaut syndrome
View details →
Orphan

Clolar

clofarabine

Genzyme Corporation

1 INDICATIONS AND USAGE Clofarabine injection is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute

Acute lymphoblastic leukemiaPrecursor T-cell acute lymphoblastic leukemia
View details →
Orphan

Lamprene

Clofazimine

Novartis Pharmaceutical Corporation

Sleep-related hypermotor epilepsyView details →
Orphan⚠️ Black Box

Duraclon

Clonidine

Roxane Laboratories, Inc.

INDICATIONS AND USAGE Duraclon is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately rel

Congenital insensitivity to pain with severe intellectual disabilitySevere generalized junctional epidermolysis bullosa
View details →
Orphan

Clotic

clotrimazole

Laboratorios Salvat, S.A.

1 INDICATIONS AND USAGE CLOTIC is indicated for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in

Transient congenital hypothyroidism due to maternal factorCHIME syndromeCongenital enteropathy due to enteropeptidase deficiency
View details →
Orphan

Mononine

Coagulation factor IX

Armour Pharmaceutical Company

1 INDICATIONS AND USAGE REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate i

View details →
Orphan

AlphaNine

Coagulation Factor IX (human)

Alpha Therapeutic Corporation

Cytomegalovirus disease in patients with impaired cell mediated immunity deemed at riskView details →
Orphan

Ixinity

COAGULATION FACTOR IX (RECOMBINANT)

Medexus Pharma, Inc.

1 INDICATIONS AND USAGE IXINITY, Coagulation Factor IX (Recombinant), is a human blood coagulation factor indicated in adults and children with hemoph

Hemophilia B
View details →
Orphan

ALPROLIX

Coagulation factor IX (recombinant), Fc fusion protein

Bioverativ Therapeutics, Inc.

Adults and children with Hemophilia B for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or

Multisystem inflammatory syndrome in children and adultsHemophilia B
View details →
Orphan

REBINYN

COAGULATION FACTOR IX RECOMBINANT, GLYCOPEGYLATED

Novo Nordisk

1 INDICATIONS AND USAGE REBINYN, Coagulation Factor IX (Recombinant), GlycoPEGylated, is a recombinant DNA-derived coagulation Factor IX concentrate i

Hemophilia BICHAD syndrome
View details →
Orphan⚠️ Black Box

NovoSeven

Coagulation factor VIIa (recombinant)

Novo Nordisk, Inc.

1 INDICATIONS AND USAGE SEVENFACT is indicated for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age

Bleeding disorder in hemophilia A carriers
View details →
Orphan⚠️ Black Box

Sevenfact

COAGULATION FACTOR VIIA RECOMBINANT HUMAN

Laboratoire Franais du Fractionnement et des Biotechnologies Socit Anonyme (LFB S.A.)

1 INDICATIONS AND USAGE SEVENFACT is indicated for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age

X-linked immune dysregulation with inflammatory bowel disease due to ELF4 deficiencyView details →
Orphan

COAGADEX

Coagulation factor X (human)

Bio Products Laboratory Limited

1 INDICATIONS AND USAGE COAGADEX, Coagulation Factor X (Human), is a plasma-derived human blood coagulation Factor indicated in adults and children wi

Congenital factor XI deficiencyMultisystem inflammatory syndrome in children and adults
View details →
Orphan⚠️ Black Box

ANDEXXA

Coagulation factor Xa (recombinant), inactivated-zhzo

Alexion Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE ANDEXXA is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life

Congenital vitamin K-dependent coagulation factors deficiencyView details →
Orphan

TRETTEN

coagulation factor XIII A-subunit (recombinant)

Novo Nordisk, Inc.

Routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency.

Moderate hemophilia ACongenital factor XIII deficiency
View details →
Orphan

Tybost

cobicistat

Gilead Sciences, Inc.

1 INDICATIONS AND USAGE TYBOST is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in

Autosomal dominant combined immunodeficiency due to ERBIN deficiencyView details →
Orphan

Cotellic

cobimetinib

Genentech, Inc.

1 INDICATIONS AND USAGE COTELLIC ® is a kinase inhibitor indicated: For the treatment of adult patients with unresectable or metastatic melanoma with

Macrophage or histiocytic tumorView details →
Orphan

Colcrys

colchicine

AR Holding Company, Inc.

1 INDICATIONS AND USAGE COLCRYS (colchicine, USP) is an alkaloid indicated for: Prophylaxis and treatment of gout flares in adults ( 1.1 ). Familial M

Familial Mediterranean fever
View details →

COLESTIPOL HYDROCHLORIDE

COLESTIPOL HYDROCHLORIDE

Amneal Pharmaceuticals of New York LLC

View details →
Orphan

Exosurf Neonatal for Intratracheal Suspension

Colfosceril palmitate, cetyl alcohol, tyloxapol

Glaxo Wellcome Inc.

Prevention of hyaline membrane disease (HMD), also known as respiratory distress syndrome (RDS), in infants born at 32 weeks gestation or less and in

Neonatal acute respiratory distress syndrome
View details →
Orphan⚠️ Black Box

XIAFLEX

collagenase clostridium histolyticum

Auxilium Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE XIAFLEX is indicated for the treatment of adult patients with Dupuytren’s contracture with a palpable cord. XIAFLEX is indicat

Marburg hemorrhagic feverDistal arthrogryposis type 10
View details →
Orphan

Alhemo

CONCIZUMAB

Novo Nordisk

1 INDICATIONS AND USAGE Alhemo is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric pat

Moderate hemophilia BHemophilia BHemophilia A
View details →
Orphan

ALIQOPA

copanlisib

Bayer US LLC

Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies

Follicular lymphoma
View details →
Orphan

Detectnet

copper Cu 64 dotatate

RadioMedix Inc.

1 INDICATIONS AND USAGE Detectnet is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neur

Serotonin-producing neuroendocrine tumor of pancreasHereditary neuroendocrine tumor of small intestine
View details →
Orphan

Zycubo

copper histidinate

Sentynl Therapeutics, Inc.

1 INDICATIONS AND USAGE ZYCUBO is indicated for the treatment of Menkes disease in pediatric patients. ZYCUBO is a copper replacement product indicate

Marburg hemorrhagic fever
View details →
Orphan

Acthrel

Corticorelin ovine triflutate

Ferring Laboratories, Inc.

To differentiate between pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushing's syndrome.

OBSOLETE: ACTH-independent Cushing syndromeACTH-dependent Cushing syndrome
View details →
Orphan

Crenessity

crinecerfont

Neurocrine Biosciences, Inc.

1 INDICATIONS AND USAGE CRENESSITY is indicated as adjunctive treatment to glucocorticoid replacement to control androgens in adults and pediatric pat

Congenital adrenal hyperplasia
View details →
← PreviousPage 7 of 32Next →

Find Additional Resources

🔬
Clinical Trials
Search recruiting trials for your condition
📖
Disease Library
Condition overviews with HPO annotations
🏥
Find Specialists
Treatment centers and rare disease experts
💊
Support Programs
Copay cards, grants, and patient assistance