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.
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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

Prolastin

Alpha1-proteinase inhibitor (human)

Bayer Corporation

For chronic replacement therapy of individuals having congenital deficiency of alpha1- proteinase inhibitor with clinically demonstrable panacinar emp

Alpha-1-antitrypsin deficiency
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Orphan

Hexalen

Altretamine

Medimmune Oncology, Inc.

Single agent palliative treatment of patients with persistent or recurrent ovarian cancer following first-line therapy with a cisplatin and/or alkylat

Clear cell adenocarcinoma of the ovaryView details →
Orphan

Gocovri

Amantadine hydrochloride

Adamas Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE GOCOVRI ® is indicated: For the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy,

Paroxysmal exertion-induced dyskinesiaYoung-onset Parkinson diseasePeroxisomal disease with epilepsy
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Orphan⚠️ Black Box

Ambrisentan

AMBRISENTAN

Cipla USA Inc.

1 INDICATIONS AND USAGE Ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients:

Pulmonary arterial hypertension
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Orphan

Firdapse

AMIFAMPRIDINE PHOSPHATE

Catalyst Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE FIRDAPSE ® is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years

Lambert-Eaton myasthenic syndrome
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Orphan

Ethyol

Amifostine

Medimmune Oncology, Inc.

1 INDICATIONS AND USAGE ETHYOL is a cytoprotective agent indicated for: – reduction of cumulative renal toxicity associated with repeated administrati

Primary hepatic neuroendocrine carcinomaView details →
Orphan

Aminocaproic Acid

AMINOCAPROIC ACID

American Regent, Inc.

INDICATIONS AND USAGE Aminocaproic Acid Injection is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening sit

Junctional epidermolysis bullosa inversaSensorineural deafness with dilated cardiomyopathyInherited epidermolysis bullosaHepatitis B reinfection following liver transplantationProgressive supranuclear palsy-pure akinesia with gait freezing syndromeCongenital amyoplasiaParkinson-dementia complex of GuamParatesticular adenocarcinoma
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Orphan

Paser Granules

Aminosalicylic acid

Jacobus Pharmaceutical Company

Treatment of tuberculosis

Primary genito-urinary tuberculosis
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Orphan

Cordarone

Amiodarone HCl

Wyeth-Ayerst Laboratories

For initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in p

Inherited isolated arrhythmogenic ventricular dysplasia, biventricular variantCatecholaminergic polymorphic ventricular tachycardia
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Orphan

Ammonium Lactate

AMMONIUM LACTATE

REMEDYREPACK INC.

INDICATIONS AND USAGE Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.

Ichthyosis VulgarisListeriosis
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Orphan

Abelcet

Amphotericin B lipid complex

Liposome Company, Inc.

Treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B therapy.

Transient predisposition to invasive pyogenic bacterial infection
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Orphan

NexoBrid

anacaulase-bcdb

Vericel Corporation

1 INDICATIONS AND USAGE NEXOBRID is indicated for eschar removal in adults and pediatric patients with deep partial thickness (DPT) and/or full thickn

Localized junctional epidermolysis bullosaPartial deep dermal and full thickness burns
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Orphan

Agrylin

Anagrelide

Takeda Development Center Americas, Inc.

1 INDICATIONS AND USAGE AGRYLIN is indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce

Essential thrombocythemiaMyeloproliferative neoplasm
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Orphan

Kineret

anakinra

Swedish Orphan Biovitrum AB (publ)

1 INDICATIONS AND USAGE KINERET is an interleukin-1 receptor antagonist indicated for: Rheumatoid Arthritis (RA) Reduction in signs and symptoms and s

CINCA syndromeDITRAJuvenile idiopathic arthritis
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Orphan

EBANGA�

ansuvimab-zykl

Emergent Manufacturing Operations Baltimore LLC

treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zair

Ebola hemorrhagic feverZika virus disease
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Orphan

BioThrax

Anthrax Vaccine Adsorbed

Emergent BioDefense Operations Lansing LLC

For post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommend

OBSOLETE: Disease predisposing to age-related macular degenerationView details →
Orphan

Cyfendus

Anthrax Vaccine Adsorbed, Adjuvanted

Emergent Product Development Gaithersburg, Inc.

post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when admini

OBSOLETE: Disease predisposing to age-related macular degeneration
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Orphan⚠️ Black Box

FEIBA

ANTI-INHIBITOR COAGULANT COMPLEX

Takeda Pharmaceuticals America, Inc.

1 INDICATIONS AND USAGE FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for: Control and

Hereditary angioedema with normal C1Inh
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Orphan

Alphanate

Antihemophilic factor (human)

Grifols Biologicals Inc.

For surgical and/or invasive procedures in patients with von Willebrand Disease (VWD) in whom desmopressin is either ineffective or contraindicated. I

Pseudo-von Willebrand diseaseVon Willebrand disease
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Orphan

Kogenate

Antihemophilic factor (recombinant)

Bayer Corporation

1 INDICATIONS AND USAGE ALTUVIIIO is indicated for use in adults and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: Rou

Rare hemorrhagic disorder due to an acquired coagulation factor defectView details →
Orphan

Eloctate

antihemophilic factor (recombinant), Fc fusion protein

Bioverativ Therapeutics, Inc.

Indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for on-demand treatment and control of bleeding episodes, perio

Moderate hemophilia A
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Orphan

ALTUVIIIO

ANTIHEMOPHILIC FACTOR (RECOMBINANT), FC-VWF-XTEN FUSION PROTEIN-EHTL

Bioverativ Therapeutics Inc.

1 INDICATIONS AND USAGE ALTUVIIIO is indicated for use in adults and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: Rou

Hemophilia AMultisystem inflammatory syndrome in children and adults
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Orphan

OBIZUR

antihemophilic factor (recombinant), porcine sequence

Takeda Development Center Americas, Inc.

Treatment of bleeding episodes in adults with acquired hemophilia A.

Rare thrombotic disorder due to a coagulation factors defectAcquired hemophilia A
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Orphan

Humate-P

Antihemophilic factor/von Willebrand factor complex (human), dried, pasteurized

CSL Behring

(1) In adult patients for treatment and prevention of bleeding in hemophilia A (classic hemophilia) and (2) in adult and pediatric patients for treatm

Pseudo-von Willebrand diseaseHemophilia AVon Willebrand disease
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Orphan

ATnativ

Antithrombin III (human)

Pharmacia & Upjohn AB

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Orphan

CroFab

Antivenin, crotalidae polyvalent immune Fab (ovine)

Protherics, Inc.

Treatment of minimal and moderate North American Crotalidae envenomation

OBSOLETE: Envenomization by Bothrops lanceolatusSnakebite envenomation
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Orphan

Adzynma

APADAMTASE ALFA

TAKEDA PHARMACEUTICALS AMERICA, INC.

1 INDICATIONS AND USAGE ADZYNMA (ADAMTS13, recombinant-krhn) is a human recombinant “A disintegrin and metalloproteinase with thrombospondin motifs 13

Immune-mediated thrombotic thrombocytopenic purpuraCongenital thrombotic thrombocytopenic purpura
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Orphan

Apokyn

Apomorphine HCl

MDD US Operations, LLC

For the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose-wearing-off" and unpredictable :on/off" episodes) associated with

Acute intermittent porphyriaPeroxisomal disease with epilepsy
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Orphan

Onapgo

apomorphine hydrochloride

MDD US Operations, LLC

1 INDICATIONS AND USAGE ONAPGO is indicated for the treatment of motor fluctuations in adults with advanced Parkinson's disease. ONAPGO is a dopaminer

Hereditary late-onset Parkinson diseaseYoung-onset Parkinson disease
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APRACLONIDINE

APRACLONIDINE

Sandoz Inc

INDICATIONS AND USAGE Apraclonidine ophthalmic solution 0.5% is indicated for short-term adjunctive therapy, in patients on maximally tolerated medica

Multiple congenital anomalies-neurodevelopmental delay-ocular abnormalities syndrome
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