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

Rifater

Rifampin, isoniazid, pyrazinamide

Hoechst Marion Roussel

Short-course treatment of tuberculosis.

Primary cutaneous tuberculosis
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Orphan

Priftin

Rifapentine

Hoechst Marion Roussel

1 INDICATIONS AND USAGE PRIFTIN is a rifamycin antimycobacterial drug indicated in patients 12 years of age and older for the treatment of active pulm

Primary pulmonary tuberculosisYersinia pseudotuberculosis infection
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Orphan

Xifaxan

rifaximin

Salix Pharmaceuticals, Inc.

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

ARX-related epileptic encephalopathyRare lens diseaseShiga toxin-associated hemolytic uremic syndrome
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Orphan

Arcalyst

rilonacept

Kiniksa Pharmaceuticals, Ltd.

1 INDICATIONS AND USAGE ARCALYST (rilonacept) is an interleukin-1 blocker indicated for: Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS),

NLRP3-associated autoinflammatory diseaseIdiopathic recurrent pericarditisFamilial cold urticariaMuckle-Wells syndromeSterile multifocal osteomyelitis with periostitis and pustulosis
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Orphan

Rilutek

Riluzole

Rhone-Poulenc Rorer Pharmaceuticals, Inc.

Treatment of patients with amyotrophic lateral sclerosis. Riluzole extends survival and/or time to tracheostomy.

Amyotrophic lateral sclerosis
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Orphan

EXSERVAN

riluzole oral film

Aquestive Therapeutics

EXSERVAN is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Amyotrophic Lateral Sclerosis (ALS)
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Orphan

Tiglutik

riluzole oral suspension

Italfarmaco SpA

1 INDICATIONS AND USAGE TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS). TIGLUTIK is indicated for the treatment of amy

Amyotrophic Lateral Sclerosis (ALS)
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Orphan

Wayrilz

rilzabrutinib

Genzyme Corporation (A Sanofi Company)

1 INDICATIONS AND USAGE WAYRILZ is indicated for the treatment of adult patients with persistent or chronic immune thrombocytopenia (ITP) who have had

Immune thrombocytopenia
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NURTEC ODT

RIMEGEPANT SULFATE

Pfizer Laboratories Div Pfizer Inc

1 INDICATIONS AND USAGE NURTEC ODT is a calcitonin gene-related peptide receptor antagonist indicated for the: acute treatment of migraine with or wit

Nodular regenerative hyperplasia of the liverView details →
Orphan⚠️ Black Box

Adempas

riociguat

Bayer

1 INDICATIONS AND USAGE Adempas is a soluble guanylate cyclase (sGC) stimulator indicated for the treatment of adults with: • Persistent/recurrent Chr

Chronic thromboembolic pulmonary hypertension
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Orphan

EVRYSDI

RISDIPLAM

Genentech, Inc.

1 INDICATIONS AND USAGE EVRYSDI is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. EVRYSDI is a survival

Spinal Muscular AtrophySpinal muscular atrophy associated with central nervous system anomaly
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Orphan

Norvir Powder for Oral Suspension

Ritonavir powder for oral suspension

AbbVie Inc.

Used in combination with other antiretroviral agents for the treatment of patients with HIV-1 infection

Congenital Epstein-Barr virus infectionView details →
Orphan⚠️ Black Box

Rituxan

rituximab

Genentech, Inc.

1 INDICATIONS AND USAGE RITUXAN HYCELA is a combination of rituximab, a CD20-directed cytolytic antibody, and hyaluronidase human, an endoglycosidase,

B-cell chronic lymphocytic leukemiaDiffuse large B-cell lymphoma
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Orphan

Rituxan SC

rituximab and recombinant human hyaluronidase

Genentech, Inc.

Treatment of adult patients with previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide ||| Treatment of

T-cell prolymphocytic leukemiaDiffuse large B-cell lymphomaFollicular lymphoma
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⚠️ Black Box

XARELTO

RIVAROXABAN

Janssen Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE XARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation

Hereditary atrial fibrillationNicolau syndromeCoronary arterial fistulaErdheim-Chester diseaseOBSOLETE: Pediatric polyarteritis nodosaBrain malformation-congenital heart disease-postaxial polydactyly syndromeIsolated splenic vein thrombosisPulmonary blastomaChronic thromboembolic pulmonary hypertensionDe novo thrombotic microangiopathy after kidney transplantation
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Orphan

Istodax

romidepsin

Celgene Corporation

1 INDICATIONS AND USAGE ISTODAX is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one pr

T-cell non-Hodgkin lymphomaPrimary cutaneous T-cell lymphoma
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Orphan

Nplate

ROMIPLOSTIM

Amgen, Inc

1 INDICATIONS AND USAGE Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in: Adult patients with immune thr

Immune thrombocytopeniaEEC syndrome and related disorders
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Orphan⚠️ Black Box

Besremi

ropeginterferon alfa-2b-njft

PharmaEssentia

1 INDICATIONS AND USAGE BESREMi is indicated for the treatment of adults with polycythemia vera. BESREMi is an interferon alfa-2b indicated for the tr

Polycythemia vera
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Orphan

Crestor

rosuvastatin

iPR Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE CRESTOR is indicated: • To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarcti

Homozygous familial hypercholesterolemiaDysbetalipoproteinemiaRare hyperlipidemiaIsolated glycerol kinase deficiencyGaucher disease-ophthalmoplegia-cardiovascular calcification syndromeAtherosclerosis-deafness-diabetes-epilepsy-nephropathy syndrome
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Orphan

Rystiggo

ROZANOLIXIZUMAB

UCB, Inc.

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

Transient neonatal myasthenia gravis
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Orphan

Rubraca

rucaparib

pharma&

1 INDICATIONS AND USAGE RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer for the maintenance treatment of adult pa

Rare ovarian cancerOBSOLETE: Familial ovarian cancerMalignant tumor of fallopian tubesPrimary peritoneal carcinomaIdiopathic steroid-resistant nephrotic syndrome
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Orphan

Banzel

rufinamide

Eisai, Inc.

1 I NDICATIONS AND USAGE BANZEL is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year

Lennox-Gastaut syndrome
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Orphan

JAKAFI

RUXOLITINIB

Incyte Corporation

1. INDICATIONS AND USAGE Jakafi is a kinase inhibitor indicated for treatment of: intermediate or high-risk myelofibrosis, including primary myelofibr

Polycythemia veraIntermediate osteopetrosisAcute graft versus host diseaseChronic graft versus host disease
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Orphan

Rydapt

RYDAPT

Novartis Pharmaceuticals Corporation

1 INDICATIONS AND USAGE RYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed acute myeloid leukemia (AML)

Acute myeloid leukemiaAcute myeloid leukaemia with myelodysplasia-related featuresAggressive systemic mastocytosisMast cell leukemiaSystemic mastocytosis with associated hematologic neoplasm
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Orphan

Sucraid

Sacrosidase

QOL Medical, LLC

INDICATIONS AND USAGE Sucraid ® (sacrosidase) Oral Solution is indicated for the treatment of sucrase deficiency, which is part of congenital sucrase-

Congenital sucrase-isomaltase deficiency
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Orphan

Kuvan

sapropterin

BioMarin Pharmaceutical, Inc.

1 INDICATIONS AND USAGE KUVAN ® is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older wit

Maternal phenylketonuria syndromeDihydropteridine reductase deficiencyPhenylketonuria
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Orphan

Sapropterin Dihydrochloride

SAPROPTERIN DIHYDROCHLORIDE

Aurobindo Pharma Limited

1 INDICATIONS AND USAGE Sapropterin dihydrochloride tablets are indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients o

Phenylketonuria
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Orphan

Leukine

Sargramostim

Immunex Corporation

1 INDICATIONS AND USAGE LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe a

Complications after hematopoietic stem cell transplantationNon-Hodgkin lymphomaAcute lymphoblastic leukemia
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Orphan

Enspryng

SATRALIZUMAB

Genentech, Inc.

1 INDICATIONS AND USAGE ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquap

Neuromyelitis optica spectrum disorder with anti-AQP4 antibodiesNeuromyelitis optica spectrum disorder
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Orphan

Oncoscint CR/OV

Satumomab pendetide

Cytogen Corporation

For determining the extent and location of extraphepatic malignant disease in patients with known colorectal and ovarian cancer.

Small cell carcinoma of the ovaryMalignant tumor of fallopian tubesRare ovarian cancer
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