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

Lantidra

donislecel-jujn

CellTrans Inc.

1 INDICATIONS AND USAGE LANTIDRA is an allogeneic pancreatic islet cellular therapy indicated for the treatment of adults with Type 1 diabetes who are

Testicular teratomaOBSOLETE: Idiopathic severe pneumococcemia
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Orphan

Modeyso

dordaviprone

Chimerix, Inc.

1 INDICATIONS AND USAGE MODEYSO is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma har

Diffuse intrinsic pontine glioma
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Orphan

Pulmozyme

Dornase alfa

Genentech, Inc.

1 INDICATIONS AND USAGE PULMOZYME ® is indicated, in conjunction with standard therapies, for the management of pediatric and adult patients with cyst

Young syndrome
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COSOPT PF

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Thea Pharma Inc.

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Orphan

Kygevvi

doxecitine and doxribtimine

UCB, Inc.

1 INDICATIONS AND USAGE KYGEVVI is indicated for the treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of

Mitochondrial DNA depletion syndrome
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Orphan⚠️ Black Box

Doxil

doxorubicin HCL liposome injection

Johnson & Johnson Pharmaceutical Research & Dev.

1 INDICATIONS AND USAGE Doxil liposomal infusion is an anthracycline topoisomerase inhibitor indicated for: • Ovarian cancer: After failure of platinu

Multiple myelomaRare ovarian cancerOBSOLETE: HIV-related Kaposi sarcoma
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DOXYCYCLINE

DOXYCYCLINE

Strides Pharma Science Limited

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, do

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

DRONABINOL

DRONABINOL

Ascend Laboratories, LLC

1 INDICATIONS AND USAGE DRONABINOL CAPSULES, USP are indicated in adults for the treatment of: anorexia associated with weight loss in patients with A

Robinow-like syndromeView details →
Orphan⚠️ Black Box

NORTHERA

droxidopa

Lundbeck LLC

1 INDICATIONS AND USAGE NORTHERA is indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black

Pure autonomic failure
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DULOXETINE HYDROCHLORIDE

DULOXETINE

Alembic Pharmaceuticals Limited

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Orphan

Dupixent

dupilumab

Regeneron Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE DUPIXENT is an interleukin-4 receptor alpha antagonist indicated: Atopic Dermatitis for the treatment of adult and pediatric p

NON RARE IN EUROPE: Eosinophilic esophagitisAllergic bronchopulmonary aspergillosisRare pulmonary disease
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Orphan

IMFINZI

durvalumab

AstraZeneca Pharmaceuticals LP

1 INDICATIONS AND USAGE IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: • in combination with platinum-containing chemothe

Adult hepatocellular carcinomaNON RARE IN EUROPE: Non-small cell lung cancerSmall cell carcinoma of the bladderConstitutional mismatch repair deficiency syndromePrimary Fanconi renotubular syndromeSmall cell lung cancerRare urinary tract tumorMucinous adenocarcinoma of the appendix
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Orphan⚠️ Black Box

COPIKTRA

duvelisib

Secura Bio, Inc.

1 INDICATIONS AND USAGE COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or sm

Precursor T-cell acute lymphoblastic leukemiaB-cell chronic lymphocytic leukemia
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Orphan⚠️ Black Box

Kalbitor

ECALLANTIDE

Takeda Pharmaceuticals America, Inc.

1 INDICATIONS AND USAGE KALBITOR ® (ecallantide) is indicated for treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of ag

Hereditary angioedema
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Orphan⚠️ Black Box

SOLIRIS

ECULIZUMAB

Alexion Pharmaceuticals Inc.

1 INDICATIONS AND USAGE SOLIRIS is a complement inhibitor indicated for: the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to r

Atypical hemolytic uremic syndromeParoxysmal nocturnal hemoglobinuriaTransient neonatal myasthenia gravis
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Orphan⚠️ Black Box

EPYSQLI

ECULIZUMAB-AAGH

Teva Pharmaceuticals USA, Inc.

1 INDICATIONS AND USAGE EPYSQLI is a complement inhibitor indicated for: the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to r

Paroxysmal nocturnal hemoglobinuriaTransient neonatal myasthenia gravisAtypical hemolytic uremic syndrome
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Orphan⚠️ Black Box

BKEMV

ECULIZUMAB-AEEB

Amgen Inc

1 INDICATIONS AND USAGE BKEMV is a complement inhibitor indicated for: The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to red

Paroxysmal nocturnal hemoglobinuriaAtypical hemolytic uremic syndromeTransient neonatal myasthenia gravis
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Orphan

Radicava

edaravone

Tanabe Pharma America Inc.

1 INDICATIONS AND USAGE RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS). RADICAVA and RADICAVA ORS ar

Amyotrophic Lateral Sclerosis (ALS)
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Orphan

Vyvgart

EFGARTIGIMOD ALFA

argenx US

1 INDICATIONS AND USAGE VYVGART is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine rec

Transient neonatal myasthenia gravis
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Orphan

Vyvgart Hytrulo

EFGARTIGIMOD ALFA AND HYALURONIDASE (HUMAN RECOMBINANT)

argenx US

1 INDICATIONS AND USAGE VYVGART HYTRULO is indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) who are anti-acetyl

Chronic inflammatory demyelinating polyneuropathyTransient neonatal myasthenia gravisOBSOLETE: Channelopathy due to a neuronal acetylcholine receptor defect
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Orphan

Iwilfin

eflornithine

USWM, LLC

1 INDICATIONS AND USAGE IWILFIN (eflornithine) is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma

EsthesioneuroblastomaNeuroblastoma
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Orphan

Ornidyl

Eflornithine HCl

Hoechst Marion Roussel

Progressive autosomal recessive ataxia-deafness syndrome
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Orphan

Kebilidi

eladocagene exuparvovec-tneq

PTC Therapeutics, Inc.

1 INDICATIONS AND USAGE KEBILIDI (eladocagene exuparvovec-tneq) is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatme

Aromatic L-amino acid decarboxylase deficiency
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Orphan

Iqirvo

elafibranor

Ipsen Bioscience Inc.

1 INDICATIONS AND USAGE IQIRVO is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in

Primary biliary cholangitis
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Orphan

Forzinity

elamipretide

Stealth Biotherapeutics, Inc.

1 INDICATIONS AND USAGE FORZINITY is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg.

Prune belly syndromeView details →
Orphan

Revcovi

elapegademase-lvlr

Chiesi USA Inc.

1 INDICATIONS AND USAGE REVCOVI is indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and ad

Short-limb skeletal dysplasia with severe combined immunodeficiencyView details →

TRIKAFTA

ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Vertex Pharmaceuticals Incorporated

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TRIKAFTA

ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Vertex Pharmaceuticals Incorporated

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TRIKAFTA

ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

Vertex Pharmaceuticals Incorporated

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Orphan⚠️ Black Box

Trikafta

elexacaftor/tezacaftor/ivacaftor

Vertex Pharmaceuticals

1 INDICATIONS AND USAGE TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one F508d

Cystic fibrosis
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