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

Cerdelga

ELIGLUSTAT

Genzyme Corporation

1 INDICATIONS AND USAGE CERDELGA is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 extensive

Gaucher diseaseFetal Gaucher disease
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Orphan⚠️ Black Box

Skysona

ELIVALDOGENE AUTOTEMCEL

Genetix Biotherapeutics Inc.

1 INDICATIONS AND USAGE SKYSONA is indicated to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral a

Neonatal adrenoleukodystrophyX-linked cerebral adrenoleukodystrophy
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Orphan⚠️ Black Box

VIMIZIM

ELOSULFASE ALFA

BioMarin Pharmaceutical Inc.

1 INDICATIONS AND USAGE VIMIZIM (elosulfase alfa) is indicated for patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome). VIMIZIM

Mucopolysaccharidosis type 4A
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Orphan

Empliciti

elotuzumab

Bristol-Myers Squibb Co.

1 INDICATIONS AND USAGE • EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple

Multiple myeloma
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⚠️ Black Box

ELREXFIO

ELRANATAMAB-BCMM

U.S. Pharmaceuticals

1 INDICATIONS AND USAGE ELREXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at le

Multiple myeloma
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⚠️ Black Box

ELTROMBOPAG

ELTROMBOPAG

Dr. Reddy's Laboratories Inc.,

1 INDICATIONS AND USAGE Eltrombopag is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patie

Immune thrombocytopeniaRare aplastic anemia
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Orphan⚠️ Black Box

Eltrombopag

ELTROMBOPAG OLAMINE

Novadoz Pharmaceuticals LLC

1 INDICATIONS AND USAGE Eltrombopag tablets are a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediat

Rare aplastic anemiaImmune thrombocytopeniaChronic encephalitis
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GAMIFANT

EMAPALUMAB-LZSG

Swedish Orphan Biovitrum AB (publ)

1 INDICATIONS AND USAGE GAMIFANT is indicated for the treatment of: adult and pediatric (newborn and older) patients with primary hemophagocytic lymph

Acquired hemophagocytic lymphohistiocytosis associated with malignant diseasePrimary hemophagocytic lymphohistiocytosis
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Orphan⚠️ Black Box

Hemlibra

EMICIZUMAB

Genentech, Inc.

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

Hemophilia AModerate hemophilia A
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Orphan⚠️ Black Box

Descovy

emtricitabine and tenofovir alafenamide

Gilead Sciences, Inc.

1 INDICATIONS AND USAGE HIV-1 Treatment ( 1.1 ): DESCOVY is a two-drug combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nu

Adenovirus infection in immunocompromised patients
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Orphan⚠️ Black Box

Idhifa

enasidenib

Celgene Corporation

1 INDICATIONS AND USAGE IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory ac

Acute myeloid leukemiaAcute myeloid leukemia with NPM1 somatic mutations
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Orphan

Braftovi

encorafenib

Array BioPharma Inc. (a wholly owned subsidiary of Pfizer Inc.)

1 INDICATIONS AND USAGE BRAFTOVI is a kinase inhibitor indicated: Melanoma • in combination with binimetinib, for the treatment of patients with unres

NON RARE IN EUROPE: Non-small cell lung cancerSmall cell lung cancerHereditary nonpolyposis colon cancerConjunctival malignant melanoma
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Orphan

ROZLYTREK

entrectinib

Genentech, Inc.

1 INDICATIONS AND USAGE ROZLYTREK is a kinase inhibitor indicated for the treatment of: Adult patients with ROS1- positive metastatic non-small cell l

RELA fusion-positive ependymomaNON RARE IN EUROPE: Non-small cell lung cancer
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Orphan⚠️ Black Box

Epkinly

epcoritamab-bysp

Genmab US, Inc.

1 INDICATIONS AND USAGE EPKINLY is a bispecific CD20-directed CD3 T-cell engager indicated: For the treatment of adult patients with relapsed or refra

Follicular lymphomaHigh grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangementEpstein-Barr virus-positive diffuse large B-cell lymphoma
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EPIPEN

EPINEPHRINE

Viatris Specialty LLC

1 INDICATIONS AND USAGE EpiPen are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g.

X-linked immune dysregulation with inflammatory bowel disease due to ELF4 deficiencyView details →
Orphan⚠️ Black Box

Ellence

Epirubicin

Pharmacia & Upjohn Company

1 INDICATIONS AND USAGE ELLENCE is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following

Rare malignant breast tumor
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Orphan

WAINUA

EPLONTERSEN

AstraZeneca Pharmaceuticals LP

1 INDICATIONS AND USAGE WAINUA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. WAINUA

Hereditary ATTR amyloidosisHereditary transthyretin-mediated amyloidosis
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Orphan⚠️ Black Box

Epogen

Epoetin alfa

Amgen, Inc.

1 INDICATIONS AND USAGE Epogen is an erythropoiesis-stimulating agent (ESA) indicated for: Treatment of anemia due to: - Chronic Kidney Disease (CKD)

Pulmonary arterial hypertension associated with congenital heart diseaseTyrosinemia type 2Trench feverAutosomal dominant tubulointerstitial kidney diseaseAlpha-heavy chain disease
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Orphan

Epoprostenol

EPOPROSTENOL

Mylan Institutional LLC

1 INDICATIONS AND USAGE Epoprostenol for injection is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve ex

Pulmonary arterial hypertension
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Orphan

Flolan

EPOPROSTENOL SODIUM

GlaxoSmithKline LLC

1 INDICATIONS AND USAGE FLOLAN is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise capacity. Tri

Pulmonary arterial hypertension
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Orphan

Halaven

eribulin mesylate

Eisai Inc.

1 INDICATIONS AND USAGE HALAVEN is a microtubule inhibitor indicated for the treatment of patients with: Metastatic breast cancer who have previously

Alveolar soft tissue sarcomaRare malignant breast tumorPleomorphic liposarcoma
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Orphan

Erwinase

Erwinia L-asparaginase

Jazz Pharmaceuticals, Inc.

Treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.

Acute lymphoblastic leukemia
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ESCITALOPRAM

ESCITSLOPRAM

Lupin Pharmaceuticals, Inc.

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SPRAVATO

ESKETAMINE HYDROCHLORIDE

Janssen Pharmaceuticals Inc.

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ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG

ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG

MARKSANS PHARMA LIMITED

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ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG

ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG

MARKSANS PHARMA LIMITED

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ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG

ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, 20 MG

MARKSANS PHARMA LIMITED

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ESTRADIOL / NORETHINDRONE ACETATE

ESTRADIOL AND NORETHINDRONE ACETATE

Breckenridge Pharmaceutical, Inc.

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Orphan⚠️ Black Box

Enbrel

etanercept

Immunex Corporation

1 INDICATIONS AND USAGE Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with: Rheumatoid Arthritis (RA)

Juvenile idiopathic arthritisFilariasisNON RARE IN EUROPE: Ankylosing spondylitisPolyarticular juvenile idiopathic arthritisPsoriasis-related juvenile idiopathic arthritis
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Orphan

Exondys 51

ETEPLIRSEN

Sarepta Therapeutics, Inc.

1 INDICATIONS AND USAGE EXONDYS 51 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of th

Duchenne muscular dystrophy
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