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

Ethamolin

Ethanolamine oleate

QOL Medical

INDICATIONS AND USAGE ETHAMOLIN Injection is indicated for the treatment of patients with esophageal varices that have recently bled, to prevent reble

Febrile infection-related epilepsy syndromeEsophageal atresia
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Orphan⚠️ Black Box

Lipiodol

ethiodized oil injection

Guerbet LLC

1 INDICATIONS AND USAGE Lipiodol is an oil-based radio-opaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and

Pediatric hepatocellular carcinomaInfantile neuroaxonal dystrophyAcute lymphoblastic leukemia
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Orphan

Didronel

Etidronate disodium

MGI Pharma, Inc.

Disorder of peroxisomal alpha-, beta- and omega-oxidation
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Orphan

HEMGENIX

ETRANACOGENE DEZAPARVOVEC

CSL Behring

1 INDICATIONS AND USAGE HEMGENIX is an adeno-associated virus vector-based gene therapy indicated for treatment of adults with Hemophilia B (congenita

Hemophilia BModerate hemophilia B
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Orphan

Waskyra

etuvetidigene autotemcel

Fondazione Telethon ETS

treatment of pediatric patients aged 6 months and older and adults with Wiskott-Aldrich Syndrome (WAS) who have a mutation in the WAS gene and for who

Wiskott-Aldrich syndrome
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Orphan

Everolimus

EVEROLIMUS

Breckenridge Pharmaceutical, Inc.

1. INDICATIONS AND USAGE Everolimus tablets are a kinase inhibitor indicated for the treatment of: Postmenopausal women with advanced hormone receptor

Renal cell carcinomaThiamine-responsive megaloblastic anemia syndromeNeuroendocrine tumor of pancreasTuberous sclerosis complexSubependymal giant cell astrocytomaNeuroendocrine tumor of stomach
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Orphan

Evkeeza

evinacumab-dgnb

Regeneron Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE EVKEEZA is indicated as an adjunct to diet and exercise and other low-density lipoprotein-cholesterol (LDL-C) lowering therapi

Homozygous familial hypercholesterolemia
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Orphan

Repatha

evolocumab

Amgen Inc.

1 INDICATIONS AND USAGE REPATHA is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke,

Homozygous familial hypercholesterolemiaTriglyceride deposit cardiomyovasculopathy
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Orphan

CASGEVY

EXAGAMGLOGENE AUTOTEMCEL

Vertex Pharmaceuticals Incorporated

1. INDICATIONS AND USAGE CASGEVY is indicated for the treatment of patients aged 12 years and older with: sickle cell disease (SCD) with recurrent vas

Sickle cell diseaseBeta-thalassemia major
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Orphan

Aromasin

Exemestane

Pharmacia & Upjohn

1 INDICATIONS AND USAGE AROMASIN is an aromatase inhibitor indicated for: • adjuvant treatment of postmenopausal women with estrogen-receptor positive

Hereditary breast cancer
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Orphan

Corifact

factor XIII concentrate (human)

CSL Behring LLC

For the routine prophylactic treatment of congenital factor XIII deficiency ||| Indicated for routine prophylactic treatment and peri-operative manage

Moderate hemophilia ACongenital factor XIII deficiency
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Orphan⚠️ Black Box

Enhertu

fam-trastuzumab deruxtecan-nxki

Daiichi Sankyo, Inc.

1 INDICATIONS AND USAGE ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated: HER2-Positive Metastatic Breast Cancer in

Adenocarcinoma of the oesophagus and oesophagogastric junctionPeripheral primitive neuroectodermal tumorHereditary breast cancerSmall cell lung cancerHereditary gastric cancer
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VABYSMO

FARICIMAB

Genentech, Inc.

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Orphan

Vowst

fecal microbiota spores, live-brpk

Aimmune Therapeutics, Inc.

1 INDICATIONS AND USAGE VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and ol

CryptosporidiosisView details →
Orphan

Rebyota

fecal microbiota, live - jslm

Ferring Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE REBYOTA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of a

Autoimmune lymphoproliferative syndrome-recurrent viral infections due to CASP8 deficiencyCoccidioidomycosisCombined immunodeficiency due to IL21R deficiency
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Orphan⚠️ Black Box

Inrebic

FEDRATINIB HYDROCHLORIDE

Celgene Corporation

1 INDICATIONS AND USAGE INREBIC ® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycyt

Primary myelofibrosisAcquired secondary polycythemia
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Orphan⚠️ Black Box

Felbamate

FELBAMATE

Taro Pharmaceuticals U.S.A., Inc.

INDICATIONS AND USAGE Felbamate oral suspension, USP is not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate oral suspensi

Lennox-Gastaut syndromePeroxisomal disease with epilepsy
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Orphan⚠️ Black Box

Fintepla

fenfluramine

UCB, Inc.

1 INDICATIONS AND USAGE FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in

Lennox-Gastaut syndromeDravet syndrome
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Orphan⚠️ Black Box

Ferabright

ferumoxytol

Covis Pharma GmbH

1 INDICATIONS AND USAGE FERABRIGHT is indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasm

Rare genetic renal diseaseMalignant melanoma of the mucosa
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Orphan

Beqvez

fidanacogene elaparvovec-dzkt

Pfizer Inc.

treatment of adults with moderate to severe hemophilia B (congenital factor IX deficiency) who: Currently use factor IX prophylaxis therapy, or; Have

Moderate hemophilia B
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Orphan

Dificid

fidaxomicin

Cubist Pharmaceuticals LLC, a subsidiary of Merck Sharp & Dohme LLC

1 INDICATIONS AND USAGE DIFICID is a macrolide antibacterial indicated in adult and pediatric patients 6 months of age and older for the treatment of

Congenital enterovirus infectionIdiopathic copper-associated cirrhosis
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Orphan

Neupogen

filgrastim

Amgen, Inc.

1 INDICATIONS AND USAGE NEUPOGEN is a leukocyte growth factor indicated to Decrease the incidence of infection‚ as manifested by febrile neutropenia‚

Congenital neutropenia
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Orphan

Omegaven

fish oil triglycerides

Fresenius Kabi USA, LLC

1 INDICATIONS AND USAGE Omegaven is indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated chole

Parenteral nutrition-associated cholestasis
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Orphan⚠️ Black Box

Qfitlia

FITUSIRAN

Genzyme Corporation

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

Moderate hemophilia BHemophilia BHemophilia A
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Orphan⚠️ Black Box

Fludara

Fludarabine phosphate

Berlex Laboratories, Inc.

1 INDICATIONS AND USAGE Fludarabine Phosphate Injection is a nucleotide metabolic inhibitor indicated for: The treatment of adult patients with B-cell

T-cell prolymphocytic leukemiaB-cell chronic lymphocytic leukemia
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Orphan

Retisert

Fluocinolone

Bausch & Lomb Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE RETISERT ® is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. RETISE

Rare genetic disorder of the posterior segment of the eyeRare disorder of the posterior segment of the eye
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Orphan

Gonal-F

Follitropin alfa, recombinant

EMD Serono, Inc.

1 INDICATIONS AND USAGE GONAL-f is indicated for: GONAL-f is a gonadotropin indicated for: Women: Induction of ovulation and pregnancy in oligo-anovul

Endocrinopathy with congenital hypogonadotropic hypogonadism as a major featureGenetic infertilityNON RARE IN EUROPE: Aldosterone-producing adenomaKallmann syndrome
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Orphan

Antizole

fomepizole

Par Pharmaceuticals, Inc

Use for suspected or confirmed methanol poisoning, either alone or in combination with hemodialysis ||| As an antidote to ethylene glycol (antifreeze)

Ethylene glycol poisoningMethanol poisoning
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FOCINVEZ

FOSAPREPITANT DIMEGLUMINE

Steriscience Specialties Private Limited

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VYALEV

FOSCARBIDOPA/FOSLEVODOPA

AbbVie Inc.

1 INDICATIONS AND USAGE VYALEV is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). VYALEV is a comb

Young-onset Parkinson disease
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