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

Grafapex

TREOSULFAN

Medexus Pharma, Inc.

1 INDICATIONS AND USAGE GRAFAPEX is an alkylating drug indicated for: Use in combination with fludarabine as a preparative regimen for allogeneic hema

Complications after hematopoietic stem cell transplantationAcute myeloid leukemiaMyelodysplastic syndrome
View details →
Orphan

Tyvaso

treprostinil

United Therapeutics

1 INDICATIONS AND USAGE Tyvaso is a prostacyclin mimetic indicated for the treatment of: Pulmonary arterial hypertension (PAH; WHO Group 1) to improve

Pulmonary arterial hypertensionPulmonary arterial hypertension associated with another disease
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Orphan

Tyvaso DPI

treprostinil inhalation powder

United Therapeutics Corporation

1 INDICATIONS AND USAGE Tyvaso DPI is a prostacyclin mimetic indicated for the treatment of: Pulmonary arterial hypertension (PAH; WHO Group 1) to imp

Pulmonary arterial hypertensionPulmonary arterial hypertension associated with another disease
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Orphan⚠️ Black Box

Vesanoid

Tretinoin

Hoffmann-La Roche, Inc.

1 INDICATIONS AND USAGE Tretinoin capsules are indicated for the induction of remission in adults and pediatric patients 1 year of age and older with

Acute promyelocytic leukemia
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Orphan

Triamcinolone Acetonide

TRIAMCINOLONE ACETONIDE

Alembic Pharmaceuticals Inc.

INDICATIONS AND USAGE Intramuscular Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectabl

View details →
Orphan

Egaten

triclabendazole

Novartis Pharmaceuticals Corporation

1 INDICATIONS AND USAGE EGATEN ® is indicated for the treatment of fascioliasis in patients 6 years of age and older. EGATEN ® tablet is an anthelmint

FasciolopsiasisView details →
Orphan

Syprine

Trientine HCl

Merck Sharp & Dohme Research

INDICATIONS AND USAGE Syprine is indicated in the treatment of patients with Wilson’s disease who are intolerant of penicillamine. Clinical experience

Wilson disease
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Orphan

Cuvrior

trientine tetrahydrochloride

Orphalan

1 INDICATIONS AND USAGE CUVRIOR is indicated for the treatment of adult patients with stable Wilson's disease who are de-coppered and tolerant to peni

Rare atrial defect and interatrial communication
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Orphan

LONSURF

trifluridine/tipiracil

Taiho Oncology, Inc.

1 INDICATIONS AND USAGE LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor

Adenocarcinoma of the oesophagus and oesophagogastric junctionGenetic gastro-esophageal diseaseHereditary nonpolyposis colon cancer
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Orphan

Dojolvi

triheptanoin

Ultragenyx Pharmaceutical, Inc.

1 INDICATIONS AND USAGE DOJOLVI is indicated as a source of calories and fatty acids for the treatment of adult and pediatric patients with molecularl

Metabolic disease due to other fatty acid oxidation disorder
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Orphan

Neutrexin

Trimetrexate glucuronate

Medimmune Oncology, Inc.

Concurrent leucovorin administration as an alternative therapy for the treatment of moderate to severe PCP in immunocompromised patients who are intol

Adenovirus infection in immunocompromised patientsLymphoid interstitial pneumonia
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Orphan

Triptodur

triptorelin pamoate

Arbor Pharmaceuticals, LLC

1 INDICATIONS AND USAGE TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).

Rare central precocious puberty
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Orphan

Daybue

TROFINETIDE

Acadia Pharmaceuticals Inc.

1 INDICATIONS AND USAGE DAYBUE and DAYBUE STIX are indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and ol

Rett syndrome
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Orphan

MembraneBlue

Trypan blue

Dutch Ophthalmic Research Center International BV

MembraneBlue 0.15% - Indications & Usage Section MembraneBlue™ 0.15% is indicated for use as an aid in ophthalmic surgery by staining the epiretinal m

Retinal degeneration-nanophthalmos-glaucoma syndrome
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Orphan

Tukysa

tucatinib

Seagen Inc.

1 INDICATIONS AND USAGE TUKYSA is a kinase inhibitor indicated: • in combination with trastuzumab and capecitabine for treatment of adult patients wit

NON RARE IN EUROPE: Colorectal cancerHereditary nonpolyposis colon cancerHereditary breast cancer
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Orphan

Ukoniq

umbralisib

TG Therapeutics, Inc.

treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen (Ind

Splenic marginal zone lymphomaView details →
Orphan⚠️ Black Box

Rinvoq

upadacitinib

AbbVie, Inc.

1 INDICATIONS AND USAGE RINVOQ/RINVOQ LQ is a Janus kinase (JAK) inhibitor. RINVOQ is indicated for the treatment of adults with moderately to severel

Juvenile idiopathic arthritis
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Orphan

Urea Cream 40 Percent

UREA

Method Pharmaceuticals, LLC

Indications and Usage For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by loc

Porokeratotic eccrine ostial and dermal duct nevusPsoriasis-related juvenile idiopathic arthritisUpington diseaseNon-amyloid monoclonal immunoglobulin deposition diseasePerivascular epithelioid cell neoplasmDermatitis herpetiformisPeeling skin syndromeListeriosisIchthyosisKeratosis pilaris atrophicansLocalized dystrophic epidermolysis bullosa, nails onlyManganese poisoningKeratoderma hereditarium mutilans
View details →
Orphan

Uracin 20%

UREA 20%

PureTek Corporation

INDICATIONS AND USAGE For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by loc

Keratoderma hereditarium mutilans
View details →
Orphan

Urea 41

UREA 41

Oncora Pharma, LLC

INDICATIONS AND USAGE Urea 41% Cream is indicated for debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly wher

Keratoderma hereditarium mutilans
View details →
Orphan

Dermacure

UREA 41%

Oncora Pharma, LLC

INDICATIONS & USAGE For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local

Manganese poisoningLocalized dystrophic epidermolysis bullosa, nails onlyDermatitis herpetiformisPsoriasis-related juvenile idiopathic arthritisListeriosisKeratoderma hereditarium mutilansKeratosis pilaris atrophicansPerivascular epithelioid cell neoplasmJoubert syndrome with oculorenal defectGlandersUpington diseasePorokeratotic eccrine ostial and dermal duct nevusPeeling skin syndromeIchthyosis
View details →
Orphan

Urea 39.5% With 2% Salicylic Acid

UREA, SALICYLIC ACID

PureTek Corporation

INDICATIONS & USAGE For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local

ListeriosisIchthyosisPerivascular epithelioid cell neoplasmKeratosis pilaris atrophicansKeratoderma hereditarium mutilansNon-amyloid monoclonal immunoglobulin deposition diseaseManganese poisoningUpington diseaseLocalized dystrophic epidermolysis bullosa, nails onlyPorokeratotic eccrine ostial and dermal duct nevusDermatitis herpetiformisPsoriasis-related juvenile idiopathic arthritis
View details →
Orphan

Metrodin

Urofollitropin

EMD Serono, Inc.

Inclusion body myopathy with Paget disease of bone and frontotemporal dementiaView details →
Orphan

URSO 250

Ursodiol

Aptalis Pharma US, Inc.

1 INDICATIONS AND USAGE URSO 250 and URSO Forte (ursodiol) tablets are indicated for the treatment of patients with primary biliary cholangitis (PBC).

Primary biliary cholangitis
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USTEKINUMAB

USTEKINUMAB

Janssen Biotech, Inc.

View details →
Orphan⚠️ Black Box

CNJ-016

Vaccinia Immune Globulin (Human) Intravenous

Cangene Corporation

1 INDICATIONS AND USAGE VIGIV (vaccinia immune globulin intravenous, human) is indicated for the treatment and/or modification of the following condit

Complication after organ transplantationView details →

VAFSEO

VADADUSTAT

Akebia Therapeutics, Inc.

View details →
Orphan⚠️ Black Box

Ingrezza

valbenazine

Neurocrine Biosciences Inc.

1 INDICATIONS AND USAGE INGREZZA and INGREZZA SPRINKLE are indicated for the treatment of adults with: - tardive dyskinesia [see Clinical Studies ( 14

Huntington diseasePulmonary arterial hypertension associated with another diseaseParoxysmal dyskinesia
View details →
Orphan

ROCTAVIAN

VALOCTOCOGENE ROXAPARVOVEC-RVOX

BioMarin Pharmaceutical Inc.

1 INDICATIONS AND USAGE ROCTAVIAN is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with severe hemophilia

Moderate hemophilia AHemophilia A
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VALPROATE SODIUM

VALPROATE SODIUM

Hikma Pharmaceuticals USA Inc.

View details →
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