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

Deferasirox oral

DEFERASIROX ORAL

Ascend Laboratories, LLC

1 INDICATIONS AND USAGE Deferasirox is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 y

Rare otorhinolaryngologic tumorView details →
Orphan⚠️ Black Box

FERRIPROX

DEFERIPRONE

Chiesi USA, Inc.

1 INDICATIONS AND USAGE FERRIPROX Tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of ag

Sickle cell-beta-thalassemia diseaseSickle cell diseaseBeta-thalassemia major
View details →
Orphan

Defitelio

defibrotide

Jazz Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE DEFITELIO is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known

Hepatic veno-occlusive diseaseComplications after hematopoietic stem cell transplantation
View details →
Orphan

Deflazacort Oral Suspension

DEFLAZACORT

Zydus Pharmaceuticals (USA) Inc.

1 INDICATIONS AND USAGE Deflazacort oral suspension is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and

Duchenne muscular dystrophy
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Orphan

Deflazacort Oral Suspension

DEFLAZACORT ORAL

Sun Pharmaceutical Industries, Inc.

1 INDICATIONS AND USAGE Deflazacort oral suspension is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and

Duchenne muscular dystrophy
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Orphan

Ablysinol

dehydrated alcohol

Belcher Pharmaceuticals, LLC

1 INDICATIONS AND USAGE Dehydrated alcohol injection is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adult

NON RARE IN EUROPE: Familial isolated hypertrophic cardiomyopathy
View details →
Orphan⚠️ Black Box

ELEVIDYS

DELANDISTROGENE MOXEPARVOVEC-ROKL

Sarepta Therapeutics, Inc.

1 INDICATIONS AND USAGE ELEVIDYS is indicated for the treatment of patients 4 years of age and older with Duchenne muscular dystrophy (DMD), who are a

Duchenne muscular dystrophy
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Orphan⚠️ Black Box

Ontak

denileukin diftitox

Eisai, Inc.

1 INDICATIONS AND USAGE LYMPHIR is indicated for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CT

Indolent primary cutaneous T-cell lymphoma
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Orphan⚠️ Black Box

Lymphir

denileukin diftitox-cxdl

Citius Oncology, Inc.

1 INDICATIONS AND USAGE LYMPHIR is indicated for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CT

Primary cutaneous T-cell lymphomaPrimary cutaneous peripheral T-cell lymphoma not otherwise specified
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Orphan

XGEVA

denosumab

Amgen, Inc.

1 INDICATIONS AND USAGE Xgeva is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myelom

Giant cell tumor of boneBenign metanephric tumorInfantile apneaMultiple myeloma
View details →
Orphan⚠️ Black Box

Desmopressin Acetate

DESMOPRESSIN ACETATE

Fresenius Kabi USA, LLC

1 INDICATIONS AND USAGE Desmopressin acetate injection is a vasopressin analog used for: Central Diabetes Insipidus - as antidiuretic replacement ther

Arginine vasopressin deficiency
View details →
⚠️ Black Box

Austedo

deutetrabenazine

Teva Pharmaceuticals

1 INDICATIONS AND USAGE AUSTEDO XR ® and AUSTEDO ® are indicated in adults for the treatment of: chorea associated with Huntington’s disease [see Clin

Huntington's Disease
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Orphan

Dexamethasone

DEXAMETHASONE

Advanced Rx Pharmacy of Tennessee, LLC

INDICATIONS AND USAGE A l l ergic States: Control of severe or incapacitating a llergic conditions intractable to adequate trials of conventional trea

Multiple myeloma
View details →
Orphan

Ozurdex

dexamethasone intravitreal implant

Allergan

1 INDICATIONS AND USAGE OZURDEX is a corticosteroid indicated for: The treatment of macular edema following branch retinal vein occlusion (BRVO) or ce

Central retinal vein occlusion
View details →
Orphan

Dexamethasone Sodium Phosphate

DEXAMETHASONE SODIUM PHOSPHATE

Hikma Pharmaceuticals USA Inc.

INDICATIONS A. Intravenous or intramuscular administration. When oral therapy is not feasible and the strength, dosage form, and route of administrati

View details →

DEXMEDETOMIDINE HYDROCHLORIDE

DEXMEDETOMIDINE HYDROCHLORIDE

Sun Pharmaceuticals Industries, Inc.

1 INDICATIONS AND USAGE Dexmedetomidine hydrochloride is a alpha 2 -adrenergic receptor agonist indicated for: • Sedation of initially intubated and m

Interatrial communicationCaudal duplication
View details →
Orphan

Totect

dexrazoxane

Clinigen, Inc.

1 INDICATIONS AND USAGE Dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin a

OBSOLETE: Anthracycline extravasation
View details →

DEXTROMETHORPHAN POLISTIREX

DEXTROMETHORPHAN POLISTIREX

Aurohealth LLC

View details →
Orphan⚠️ Black Box

VALTOCO

diazepam (intranasal)

Neurelis Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE VALTOCO ® is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizu

Folinic acid-responsive seizuresView details →
Orphan

Diastat

Diazepam viscous solution for rectal administration

Valeant Pharmaceuticals

Febrile infection-related epilepsy syndromeView details →
Orphan

Vykat Xr

DIAZOXIDE CHOLINE

Soleno Therapeutics, Inc.

1 INDICATIONS AND USAGE VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-W

Prader-Willi syndrome
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LICART

DICLOFENAC EPOLAMINE

IBSA Pharma Inc.

View details →
Orphan

Durezol

difluprednate

Alcon Pharmaceuticals. Ltd.

1 INDICATIONS AND USAGE DUREZOL ® is a corticosteroid indicated for: • The treatment of inflammation and pain associated with ocular surgery. ( 1.1 )

Granulomatous arthritis of childhoodView details →
Orphan

Digibind

Digoxin immune FAB (Ovine)

Glaxo Wellcome Inc.

Rare disorder potentially indicated for transplant or complication after transplantation
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MATZIM LA

DILTIAZEM HYDROCHLORIDE

Actavis Pharma, Inc.

View details →
Orphan⚠️ Black Box

Unituxin

dinutuximab

United Therapeutics Corporation

1 INDICATIONS AND USAGE Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleuki

EsthesioneuroblastomaNeuroblastoma
View details →

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

SpecGx LLC

View details →

DEPAKOTE

DIVALPROEX SODIUM

AbbVie Inc.

View details →

ABREVA

DOCOSANOL

Haleon US Holdings LLC

View details →
Orphan

DAWNZERA

DONIDALORSEN

Ionis Pharmaceuticals Inc.

1 INDICATIONS AND USAGE DAWNZERA™ is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 ye

Hereditary angioedema
View details →
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