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⚠️ Black Box

Blincyto

blinatumomab

Amgen, Inc.

1 INDICATIONS AND USAGE BLINCYTO is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adult and pediatric patients one mont

Acute lymphoblastic leukemiaPrecursor T-cell acute lymphoblastic leukemia
View details →
Orphan

Velcade

bortezomib

Takeda Pharmaceuticals U.S.A., Inc.

1 INDICATIONS AND USAGE VELCADE is a proteasome inhibitor indicated for: treatment of adult patients with multiple myeloma ( 1.1 ) treatment of adult

Multiple myelomaMantle cell lymphoma
View details →
Orphan⚠️ Black Box

Bosentan

BOSENTAN

Actavis Pharma, Inc.

1 INDICATIONS AND USAGE Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): in adults to improve

Pulmonary arterial hypertension
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Orphan

Bosulif

bosutinib

PF PRISM C.V.

1 INDICATIONS AND USAGE BOSULIF is indicated for the treatment of: • Adult and pediatric patients 1 year of age and older with chronic phase (CP) Phil

Chronic myeloid leukemiaFamilial platelet disorder with associated myeloid malignancy
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Orphan⚠️ Black Box

Botox

botulinum toxin type A

Allergan, Inc.

1 INDICATIONS AND USAGE BOTOX is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: Treatment of overactive bladder

NON RARE IN EUROPE: Idiopathic facial palsyView details →
Orphan⚠️ Black Box

Myobloc

Botulinum toxin type B

Soltice Neurosciences, LLC

1 INDICATIONS AND USAGE MYOBLOC is an acetylcholine release inhibitor indicated for: Treatment of cervical dystonia to reduce the severity of abnormal

OBSOLETE: Cervical dystoniaPrP systemic amyloidosis
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Orphan

BabyBIG

Botulism immune globulin

California Department of Public Health

1 INDICATIONS AND USAGE BabyBIG ® , Botulism Immune Globulin Intravenous (Human), is indicated for the treatment of infant botulism caused by toxin ty

Infant botulism
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Orphan⚠️ Black Box

Adcetris

brentuximab vedotin

Seagen Inc.

1 INDICATIONS AND USAGE ADCETRIS is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of: • Adult patients with pre

Classic Hodgkin lymphoma, nodular sclerosis typeALK-negative anaplastic large cell lymphomaPrimary cutaneous anaplastic large cell lymphomaClassic mycosis fungoidesClassic Hodgkin lymphoma
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Orphan⚠️ Black Box

TECARTUS�

brexucabtagene autoleucel

Kite Pharma, Inc.

1 INDICATIONS AND USAGE TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: TECARTUS is a

Mantle cell lymphomaPrecursor T-cell acute lymphoblastic leukemia
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Orphan

Alunbrig

brigatinib

Takeda Development Center Americas, Inc.

1 INDICATIONS AND USAGE ALUNBRIG is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small

MIRAGE syndromeNON RARE IN EUROPE: Non-small cell lung cancer
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Orphan

DORC ILM-Blue

Brilliant Blue G Ophthalmic Solution 0.025%

Dutch Ophthalmic Research Center International BV

TissueBlue (Brilliant Blue G Ophthalmic Solution) 0.025% is indicated to selectively stain the internal limiting membrane (ILM).

Rare genetic ophthalmic disorder with cortical involvement
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Orphan⚠️ Black Box

Tembexa

brincidofovir

Emergent BioDefense Operations Lansing LLC

1 INDICATIONS AND USAGE TEMBEXA is an orthopoxvirus nucleotide analog DNA polymerase inhibitor and is indicated for the treatment of human smallpox di

Small bowel atresiaHuman prion disease
View details →
Orphan

Eohilia

budesonide

Takeda Pharmaceuticals U.S.A., Inc.

1 INDICATIONS AND USAGE EOHILIA ™ is indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic e

NON RARE IN EUROPE: Eosinophilic esophagitis
View details →
Orphan

Tarpeyo

budesonide delayed-release

Calliditas Therapeutics

1 INDICATIONS AND USAGE TARPEYO is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are

IgA NephropathyProgressive dementia with neuroserpin inclusion bodiesImmunoglobulin A nephropathy
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Orphan

Elliotts B Solution

Buffered intrathecal electrolyte/dextrose injection

Lukare Medical, LLC

For the intrathecal administration of methotrexate and cytarabine for the prevention or treatment of meningeal leukemia and lymphocytic lymphoma.

Arginine vasopressin resistance-intracranial calcification-short stature-facial dysmorphism syndromeView details →

BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE

Anthea Pharma Private Limited

View details →

BUPRENORPHINE AND NALOXONE

BUPRENORPHINE AND NALOXONE

Dr.Reddys Laboratories Inc

View details →
Orphan

Suboxone

buprenorphine in combination with naloxone

Indivior, Inc.

1 INDICATIONS AND USAGE SUBOXONE sublingual film is indicated for treatment of opioid dependence. SUBOXONE sublingual film should be used as part of a

OBSOLETE: Radiation-induced hypopituitarismView details →

BUPROPION HYDROCHLORIDE SR

BUPROPION HYDROCHLORIDE

Slate Run Pharmaceuticals, LLC

View details →
Orphan

Crysvita

burosumab-twza

Kyowa Kirin, Inc.

1 INDICATIONS AND USAGE CRYSVITA is a fibroblast growth factor 23 (FGF23) blocking antibody indicated for: The treatment of X-linked hypophosphatemia

X-linked hypophosphatemia
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BUSPIRONE HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE

Oxford Pharmaceuticals, LLC

View details →
Orphan⚠️ Black Box

Busulfex

Busulfan

Otsuka Pharmaceutical Company, Ltd

1 INDICATIONS AND USAGE BUSULFEX is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic

Rare disorder potentially indicated for transplant or complication after transplantationChronic myeloid leukemia
View details →
Orphan

Berinert

C1 esterase inhibitor (human)

CSL Behring LLC

Treatment of acute attacks of hereditary angioedema.

Renin-angiotensin-aldosterone system-blocker-induced angioedemaView details →
Orphan

Ruconest

C1 ESTERASE INHIBITOR RECOMBINANT

Pharming Healthcare Inc.

1 INDICATIONS AND USAGE RUCONEST is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patient

Hereditary angioedema
View details →
Orphan

Haegarda

C1 esterase inhibitor subcutaneous (human)

CSL Behring LLC

For routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients. ||| HAEGARDA is a plasma-derived concentrate

Hereditary angioedema
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CABERGOLINE

CABERGOLINE

SOLA Pharmaceuticals, LLC

INDICATIONS AND USAGE Cabergoline Tablets, USP are indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary

Prolactinoma
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Orphan

CABOMETYX

cabozantinib

Exelixis, Inc.

1 INDICATIONS AND USAGE CABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) pati

Undifferentiated carcinoma of liver and intrahepatic biliary tractRenal cell carcinomaHepatocellular carcinomaDifferentiated thyroid carcinomaNeuroendocrine tumor of pancreas
View details →
Orphan

Cafcit

Caffeine

O.P.R. Development, L.P.

INDICATIONS AND USAGE CAFCIT (caffeine citrate) is indicated for the treatment of apnea of prematurity.

Apnea of prematurity
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CALCIPOTRIENE

CALCIPOTRIENE

Glenmark Pharmaceuticals Inc.,USA

View details →
Orphan

Cibacalcin

Calcitonin-human for injection

Novartis Pharmaceutical Corporation

Free sialic acid storage disease, infantile formView details →
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