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

Kymriah (tisagenlecleucel)

(tisagenlecleucel) Autologous T Cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19

Novartis Pharmaceuticals Corporation

Treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse

Precursor T-cell acute lymphoblastic leukemia
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Orphan

Gleolan

5-aminolevulinic acid

NX Development Corporation

1 INDICATIONS AND USAGE Gleolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imagi

Multifocal infantile hemangioma with extracutenous involvementView details →
Orphan

Orencia

abatacept

Bristol-Myers Squibb Co.

1 INDICATIONS AND USAGE ORENCIA is a selective T cell costimulation modulator indicated for: • the treatment of adult patients with moderately to seve

Juvenile idiopathic arthritisPolyarticular juvenile idiopathic arthritis
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Orphan

CALQUENCE

acalabrutinib

Acerta Pharma, LLC (a member of the AstraZeneca Group)

1 INDICATIONS AND USAGE CALQUENCE is a kinase inhibitor indicated: • In combination with bendamustine and rituximab for the treatment of adult patient

Mantle cell lymphomaB-cell chronic lymphocytic leukemia
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ACETAZOLAMIDE

ACETAZOLAMIDE

ANI Pharmaceuticals, Inc.

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Orphan

Acetylcysteine

ACETYLCYSTEINE

Hospira, Inc.

INDICATIONS AND USAGE Acetylcysteine is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions in such con

Paracetamol poisoningMounier-Kühn syndromePulmonary arterial hypertension associated with another diseaseIdiopathic bronchiectasisPneumoconiosisB-cell chronic lymphocytic leukemiaPlastic bronchitisCystic fibrosisAccessory pancreasComplication in hemodialysisOBSOLETE: Posttraumatic hypopituitarismSelective intrauterine growth restrictionTuberculosisGelatinous drop-like corneal dystrophy
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Orphan

Cetylev

acetylcysteine effervescent tablets for oral solution

Arbor Pharmaceuticals, Inc.

Indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion

NON RARE IN EUROPE: Peyronie syndromeParacetamol poisoning
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Orphan

Attruby

ACORAMIDIS HYDROCHLORIDE

BridgeBio Pharma, Inc.

1 INDICATIONS AND USAGE ATTRUBY is indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-

Hereditary transthyretin-mediated amyloidosis
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Orphan

Avaclyr

acyclovir

Fera Pharmaceuticals

1 INDICATIONS AND USAGE AVACLYR is a sterile topical antiviral indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in patients

OBSOLETE: Herpes simplex virus keratitis
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KRAZATI

ADAGRASIB

Mirati Therapeutics, Inc

1 INDICATIONS AND USAGE KRAZATI is an inhibitor of the RAS GTPase family indicated for: Non-small cell lung cancer (NSCLC)* • As a single agent, for t

Small cell lung cancer
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Orphan⚠️ Black Box

HUMIRA

adalimumab

AbbVie, Inc.

1 INDICATIONS AND USAGE HUMIRA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms, inducing major clinical response,

NON RARE IN EUROPE: Hidradenitis suppurativaPediatric-onset Graves diseaseChronic beryllium diseaseInfectious panuveitisBronchiolitis obliteransNON RARE IN EUROPE: Ankylosing spondylitisJuvenile idiopathic arthritisPolyarticular juvenile idiopathic arthritisPsoriasis-related juvenile idiopathic arthritis
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Orphan

SCENESSE

afamelanotide

Clinuvel Inc.

SCENESSE ® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyr

Erythropoietic porphyria
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Orphan⚠️ Black Box

Tecelra

afamitresgene autoleucel

USWM CT, LLC

1 INDICATIONS AND USAGE TECELRA is a melanoma-associated antigen A4-(MAGE-A4)-directed genetically modified autologous T cell immunotherapy indicated

Alveolar soft tissue sarcomaMegacystis-megaureter syndrome
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Orphan

Gilotrif

afatinib

Boehringer Ingelheim Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE GILOTRIF is a kinase inhibitor indicated for: First-line treatment of patients with metastatic non-small cell lung cancer (NSC

NON RARE IN EUROPE: Non-small cell lung cancerSmall cell lung cancer
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Orphan⚠️ Black Box

Myqorzo

aficamten

Cytokinetics Inc.

1 INDICATIONS AND USAGE MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve fu

Non-familial hypertrophic cardiomyopathyRare hypertrophic cardiomyopathy
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Orphan

Eylea

aflibercept

Regeneron Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE EYLEA HD is indicated for the treatment of: EYLEA HD is a vascular endothelial growth factor (VEGF) inhibitor indicated for th

Retinopathy of prematurityCentral retinal vein occlusionNON RARE IN EUROPE: Age-related macular degenerationCystoid macular dystrophyDiabetic embryopathy
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Orphan⚠️ Black Box

Fabrazyme

AGALSIDASE BETA

Genzyme Corporation

1 INDICATIONS AND USAGE FABRAZYME ® is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disea

Fabry disease
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Orphan

Albenza

Albendazole

Impax Laboratories, LLC

1 INDICATIONS AND USAGE ALBENZA is an anthelmintic drug indicated for: Treatment of parenchymal neurocysticercosis due to active lesions caused by lar

Cysticercosis
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Orphan⚠️ Black Box

Proleukin

Aldesleukin

Chiron Corporation

1 INDICATIONS AND USAGE Proleukin is a lymphocyte growth factor indicated for: The treatment of adults with metastatic renal cell carcinoma. ( 1.1 ) T

MiT family translocation renal cell carcinoma
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Orphan

Alecensa

alectinib

Hoffmann-La Roche, Inc. (c/o Genentech, Inc.)

1 INDICATIONS AND USAGE ALECENSA is a kinase inhibitor indicated for: adjuvant treatment in adult patients following tumor resection of anaplastic lym

NON RARE IN EUROPE: Non-small cell lung cancer
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Orphan⚠️ Black Box

Campath

alemtuzumab

Genzyme Corporation

1 INDICATIONS AND USAGE CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-dir

T-cell prolymphocytic leukemiaB-cell chronic lymphocytic leukemia
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ALENDRONATE SODIUM

ALENDRONATE SODIUM

Aurobindo Pharma Limited

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Orphan

Ceredase

Alglucerase injection

Genzyme Corporation

Long-term enzyme replacement therapy for children, adolescents and adult patients with a confirmed diagnosis of Type I Gaucher disease who exhibit sig

Fetal Gaucher diseaseGaucher disease
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Orphan⚠️ Black Box

Lumizyme

ALGLUCOSIDASE ALFA

Genzyme Corporation

1 INDICATIONS AND USAGE LUMIZYME ® is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (acid α-glucosidase [G

Pompe disease
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Orphan

Praluent

alirocumab

Regeneron Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE PRALUENT ® is indicated: To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocard

Homozygous familial hypercholesterolemiaTriglyceride deposit cardiomyovasculopathy
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Orphan

Panretin

Alitretinoin

Advanz Pharma (US) Corp.

1 INDICATIONS AND USAGE 1.1 Kaposi’s Sarcoma PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s

OBSOLETE: HIV-related Kaposi sarcoma
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Orphan

StrataGraft

allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat

Stratatech Corporation, a Mallinckrodt company

Treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickne

XMENPartial deep dermal and full thickness burns
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Orphan

Rethymic

allogeneic processed thymus tissue-agdc

Enzyvant Therapeutics GmbH

1 INDICATIONS AND USAGE RETHYMIC ® is indicated for immune reconstitution in pediatric patients with congenital athymia. RETHYMIC is indicated for imm

T-cell immunodeficiency with thymic aplasia
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Orphan

Aloprim for Injection

Allopurinol sodium

Catalytica Pharmaceuticals, Inc

1 INDICATIONS AND USAGE Allopurinol Sodium for Injection is indicated for the management of adult and pediatric patients with leukemia, lymphoma, and

View details →
Orphan

Vijoice

alpelisib

Novartis Pharmaceuticals Corporation

1 INDICATIONS AND USAGE VIJOICE is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of

PIK3CA-related overgrowth syndrome
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