FDA-Approved Treatments

Drugs with orphan designation or indications for rare diseases — 970 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⚠️ Black Box

KANUMA

SEBELIPASE ALFA

Alexion Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE KANUMA ® is indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency. KANUMA ® is a

Lysosomal acid lipase deficiency
View details →
Orphan

EKTERLY

SEBETRALSTAT

KalVista Pharmaceuticals Ltd

1 INDICATIONS AND USAGE EKTERLY® is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 1

Hereditary angioedema
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COSENTYX

SECUKINUMAB

Novartis Pharmaceuticals Corporation

View details →
Orphan

Livdelzi

seladelpar

Gilead Sciences, Inc.

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

Primary biliary cholangitis
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Orphan

Eldepryl

Selegiline HCl

Somerset Pharmaceuticals, Inc.

Developmental delay-language impairment-dopa responsive dystonia-parkinsonism syndrome due to 2q24 microdeletionView details →
Orphan

Uptravi

selexipag

Janssen

1 INDICATIONS AND USAGE UPTRAVI is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) t

Pulmonary arterial hypertension
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Orphan

XPOVIO

selinexor

Karyopharm Therapeutics, Inc.

1 INDICATIONS AND USAGE XPOVIO is a nuclear export inhibitor indicated: In combination with bortezomib and dexamethasone for the treatment of adult pa

Multiple myeloma
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Orphan

RETEVMO

selpercatinib

Loxo Oncology Inc., a wholly owned subsidiary of Eli Lilly and Company

1 INDICATIONS AND USAGE RETEVMO ® is a kinase inhibitor indicated for the treatment of: Adult patients with locally advanced or metastatic non-small c

Medullary thyroid carcinomaNON RARE IN EUROPE: Non-small cell lung cancer
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Orphan

Koselugo

selumetinib

AstraZeneca / Alexion

1 INDICATIONS AND USAGE KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1

Mosaic neurofibromatosis type 1Neurofibromatosis type 1
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⚠️ Black Box

WEGOVY

SEMAGLUTIDE

Novo Nordisk

1 INDICATIONS AND USAGE WEGOVY injection is indicated in combination with a reduced calorie diet and increased physical activity: • To reduce the risk

High-grade dysplasia in patients with Barrett esophagusIgG4-related sclerosing cholangitisSTING-associated vasculopathy with onset in infancyGenetic obesity
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Orphan

Sephience

SEPIAPTERIN

PTC Therapeutics Inc.

1 INDICATIONS AND USAGE SEPHIENCE is indicated for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and old

Maternal phenylketonuria syndromePhenylketonuria
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Orphan

Geref

Sermorelin acetate

EMD Serono, Inc.

Isolated growth hormone deficiency type IIView details →

IMCIVREE

SETMELANOTIDE

Rhythm Pharmaceuticals, Inc

1 INDICATIONS AND USAGE IMCIVREE is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients ag

Bardet-Biedl syndromeObesity due to pro-opiomelanocortin deficiency
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Orphan

Hyrnuo

sevabertinib

Bayer HealthCare Pharmaceuticals Inc.

1 INDICATIONS AND USAGE HYRNUO is indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung c

Upper tract urothelial carcinomaView details →
Orphan

Voyxact

sibeprenlimab

Otsuka

1 INDICATIONS AND USAGE VOYXACT is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease prog

IgA NephropathyImmunoglobulin A nephropathy
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Orphan

Sildenafil

SILDENAFIL

Asclemed USA, Inc.

1 INDICATIONS & USAGE Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercis

Pulmonary arterial hypertension
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Orphan

Sildenafil

SILDENAFIL CITRATE

ANI Pharmaceuticals, Inc.

1 INDICATIONS & USAGE Adults Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Orga

Pulmonary arterial hypertension
View details →
Orphan

Sildenafil

SILDENAFIL POWDER,

Camber Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE Adults Sildenafilfororal suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Orga

Idiopathic/heritable pulmonary arterial hypertensionPulmonary arterial hypertension
View details →
Orphan

SYLVANT

siltuximab

Recordati Rare Diseases Inc.

1 INDICATIONS AND USAGE SYLVANT is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency

Unicentric Castleman disease
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Orphan

Hyftor

SIROLIMUS

Nobelpharma America, LLC

1 INDICATIONS AND USAGE HYFTOR is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric patien

Multiple paragangliomas associated with polycythemia
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Orphan

Fyarro

sirolimus protein-bound particles for injectable suspension (albumin-bound)

Aadi Bioscience, Inc.

1 INDICATIONS AND USAGE FYARRO ™ is indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascu

Perivascular epithelioid cell neoplasm
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RINGERS

SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE

ICU Medical, Inc.

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RINGERS

SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE

ICU Medical, Inc.

1 INDICATIONS AND USAGE Ringer’s Injection is indicated for use as a source of water and electrolytes in adults and pediatric patients. Ringer’s Injec

Osteopetrosis and related disordersIsolated delta-storage pool disease
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RINGERS

SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE

ICU Medical, Inc.

1 INDICATIONS AND USAGE Ringer’s Injection is indicated for use as a source of water and electrolytes in adults and pediatric patients. Ringer’s Injec

AchromatopsiaView details →

RINGERS

SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE

ICU Medical, Inc.

1 INDICATIONS AND USAGE Ringer’s Injection is indicated for use as a source of water and electrolytes in adults and pediatric patients. Ringer’s Injec

Isolated delta-storage pool diseaseOsteopetrosis and related disorders
View details →

RINGERS

SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE

ICU Medical, Inc.

View details →

RINGERS

SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE

ICU Medical, Inc.

View details →

RINGERS

SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE

ICU Medical, Inc.

View details →

RINGERS

SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE

ICU Medical, Inc.

View details →

RINGERS

SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE

ICU Medical, Inc.

View details →
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