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

ADAKVEO

CRIZANLIZUMAB

Novartis Pharmaceuticals Corporation

1 INDICATIONS AND USAGE ADAKVEO ® is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged 16 years

Sickle cell disease
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Orphan

Xalkori

crizotinib

Pfizer, Inc.

1 INDICATIONS AND USAGE XALKORI is a kinase inhibitor indicated for the treatment of • adult patients with metastatic non-small cell lung cancer (NSCL

ALK-negative anaplastic large cell lymphomaNON RARE IN EUROPE: Non-small cell lung cancerALK-positive anaplastic large cell lymphomaInflammatory myofibroblastic tumor
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Orphan

Gastrocrom

Cromolyn sodium

Fisons Corporation

INDICATIONS AND USAGE GASTROCROM is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvemen

Cutaneous mastocytosis
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Orphan

Opticrom 4% ophthalmic solution

Cromolyn sodium 4% ophthalmic solution

Fisons Corporation

Vernal keratoconjunctivitis
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Orphan

Anavip

crotalidae immune F(ab')2 (equine)

Rare Disease Therapeutics, Inc.

Management of adult and pediatric patients with North American rattlesnake envenomation ||| For the management of adult and pediatric patients with No

OBSOLETE: Envenomization by Bothrops lanceolatusSnakebite envenomation
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Orphan⚠️ Black Box

Piasky

CROVALIMAB

Genentech, Inc.

1 INDICATIONS AND USAGE PIASKY is indicated for the treatment of adult and pediatric patients 13 years and older with paroxysmal nocturnal hemoglobinu

Paroxysmal nocturnal hemoglobinuria
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Orphan

Verkazia

cyclosporine

Harrow Eye, LLC

1 INDICATIONS AND USAGE Verkazia ophthalmic emulsion is indicated for the treatment of vernal keratoconjunctivitis (VKC) in children and adults. Verka

Vernal keratoconjunctivitis
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Orphan

Cystagon

Cysteamine

Mylan Laboratories, Inc.

INDICATIONS AND USAGE CYSTAGON ® is indicated for the management of nephropathic cystinosis in children and adults.

Ocular cystinosisView details →
Orphan

PROCYSBI

cysteamine enteric coated

Horizon Therapeutics USA, Inc.

1 INDICATIONS AND USAGE PROCYSBI is indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older. P

Ocular cystinosis
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Orphan

Cystaran

Cysteamine hydrochloride

Leadiant Biosciences, Inc.

1 INDICATIONS AND USAGE CYSTARAN ® is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with c

Adenovirus infection in immunocompromised patientsNeurodegeneration with brain iron accumulation
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Orphan

DepoCyt

Cytarabine liposomal

Pacira Pharmaceuticals, Inc.

Intrathecal treatment of lymphomatous meningitis.

Paraneoplastic uveitisOBSOLETE: Lymphomatous meningitis
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Orphan

VYXEOS

Cytarabine:daunorubicin liposome injection; daunorubicin and cytarabine (liposome); daunorubicin and cytarabine liposome for injection

Celator Pharmaceuticals, Inc. (a Jazz Pharmaceuticals Company)

treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatr

Acute myeloid leukemiaAcute myeloid leukaemia with myelodysplasia-related features
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Orphan

CytoGam

Cytomegalovirus immune globulin (human)

CSL Behring LLC

#1) Attenuation of primary CMV disease associated with kidney transplant recipients who are seronegative for CMV and who receive a kidney from a CMV s

Severe disseminated cytomegalovirus infection in immunocompetent patientsRecurrent hepatitis C virus induced liver disease in liver transplant recipients
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Orphan

TAFINLAR

dabrafenib

Novartis Pharmaceuticals Corp.

1 INDICATIONS AND USAGE TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melan

NON RARE IN EUROPE: Non-small cell lung cancer
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Orphan

Tafinlar Capsules and Mekinist Tablets

dabrafenib and trametinib

Novartis Pharmaceuticals Corporation

MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (AT

Anaplastic thyroid carcinoma
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Orphan

Zenapax

Daclizumab

Hoffmann-La Roche, Inc.

Prophylaxis of acute organ rejection in patients receiving renal transplants, to be used as a part of an immunosuppressive regimen that includes cyclo

Vein of Galen malformationOBSOLETE: Graft rejection after lung transplantation
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Orphan

VIZIMPRO

dacomitinib

Pfizer, Inc.

1 INDICATIONS AND USAGE VIZIMPRO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epiderm

NON RARE IN EUROPE: Non-small cell lung cancerMale infertility with spermatogenesis disorder due to single gene mutation
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Orphan

Ampyra

dalfampridine

Acorda Therapeutics

1 INDICATIONS AND USAGE AMPYRA is indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by

NON RARE IN EUROPE: Multiple sclerosis
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Orphan⚠️ Black Box

Danazol

DANAZOL

Chartwell RX, LLC.

INDICATIONS AND USAGE Endometriosis. Danazol capsules are indicated for the treatment of endometriosis amenable to hormonal management. Hereditary Ang

Extrapelvic endometriosisHereditary angioedema
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Orphan⚠️ Black Box

Voydeya

DANICOPAN

Alexion Pharmaceuticals Inc.

1 INDICATIONS AND USAGE VOYDEYA is indicated as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adul

Paroxysmal nocturnal hemoglobinuria
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Orphan

RYANODEX

dantrolene sodium suspension for injection

Eagle Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE RYANODEX ® is indicated for the: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures [see

Multiple pterygium-malignant hyperthermia syndrome
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DAPAGLIFLOZIN

DAPAGLIFLOZIN

Alembic Pharmaceuticals Inc.

View details →

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Lupin Pharmaceuticals, Inc.

View details →
Orphan

Darzalex

daratumumab

Janssen Biotech, Inc.

1 INDICATIONS AND USAGE DARZALEX FASPRO is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase, in

Multiple myelomaLight Chain (AL) Amyloidosis
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Orphan

Darzalex Faspro

DARATUMUMAB AND HYALURONIDASE-FIHJ (HUMAN RECOMBINANT)

Janssen Biotech, Inc.

1 INDICATIONS AND USAGE DARZALEX FASPRO is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase, in

Multiple myelomaLight Chain (AL) Amyloidosis
View details →
Orphan

Phyrago

dasatinib

Handa Therapeutics, LLC

1. INDICATIONS AND USAGE PHYRAGO is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic

B-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2)
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Orphan

DaunoXome

Daunorubicin citrate liposome injection

NeXstar Pharmaceuticals, Inc.

First line cytotoxic therapy for advanced, HIV related Kaposi's sarcoma.

OBSOLETE: HIV-related Kaposi sarcoma
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Orphan⚠️ Black Box

Daxxify

daxibotulinumtoxinA-lanm

Revance Therapeutics, Inc.

1 INDICATIONS AND USAGE DAXXIFY is an acetylcholine release inhibitor and neuromuscular-blocking agent indicated for: Temporary improvement in the app

OBSOLETE: Cervical dystoniaView details →
Orphan

Decitabine

DECITABINE

BluePoint Laboratories

1 INDICATIONS AND USAGE Decitabine for Injection is indicated for treatment of adult patients with myelodysplastic syndromes (MDS) including previousl

Myelodysplastic syndrome
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Orphan⚠️ Black Box

Deferasirox

DEFERASIROX

MSN LABORATORIES PRIVATE LIMITED

1 INDICATIONS AND USAGE Deferasirox tablets are an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in pat

Rare disorder due to unbalanced inter-twin blood transfusionBeta-thalassemia intermedia
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