FDA-Approved Treatments

Drugs with orphan designation or indications for rare diseases — 964 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.

⚠️ Black Box

XEOMIN

INCOBOTULINUMTOXINA

Merz Pharmaceuticals, LLC

1 INDICATIONS AND USAGE XEOMIN is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment or improvement of: C

X-linked Ehlers-Danlos syndromeView details →

IC-GREEN

INDOCYANINE GREEN

Renew Pharmaceuticals Limited

View details →
Orphan

Uplizna

INEBILIZUMAB

Horizon Therapeutics USA, Inc.

1 INDICATIONS AND USAGE UPLIZNA is a CD19-directed cytolytic antibody indicated for the treatment of: Neuromyelitis optica spectrum disorder (NMOSD) i

Neuromyelitis optica spectrum disorderTransient neonatal myasthenia gravisIgG4-related disease
View details →
Orphan

Truseltiq

infigratinib

QED Therapeutics, Inc.

Treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2

Combined hepatocellular carcinoma and cholangiocarcinoma
View details →
Orphan⚠️ Black Box

Remicade

infliximab

Janssen Biotech, Inc.

1 INDICATIONS AND USAGE REMICADE is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease : reducing signs and symptoms and inducing an

NON RARE IN EUROPE: Ulcerative colitisJuvenile idiopathic arthritisBartonella bacilliformis infectionPediatric multiple sclerosisPsoriasis-related juvenile idiopathic arthritisFilariasisPediatric-onset Graves diseaseNON RARE IN EUROPE: Ankylosing spondylitisPeroxisomal disease with epilepsy
View details →
Orphan

Tegsedi

inotersen

Ionis/AstraZeneca

Indicated for polyneuropathy of hATTR amyloidosis in adults.

Hereditary ATTR amyloidosis
View details →
Orphan⚠️ Black Box

Besponsa

inotuzumab ozogamicin

Wyeth Pharmaceuticals, LLC

1. INDICATIONS AND USAGE BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia

Precursor B-cell acute lymphoblastic leukemiaPrecursor T-cell acute lymphoblastic leukemia
View details →
Orphan

Roferon A

Interferon alfa-2a

Hoffmann-La Roche, Inc.

Treatment of chronic myelogenous leukemia.

Chronic myeloid leukemia
View details →
Orphan

Roferon-A

Interferon alfa-2a (recombinant)

Hoffmann-La Roche, Inc.

OBSOLETE: HIV-related Kaposi sarcoma
View details →
Orphan

Intron A

Interferon alfa-2b (recombinant)

Schering Corporation

Treatment of selected patients with AIDS-related Kaposi's sarcoma.

OBSOLETE: HIV-related Kaposi sarcoma
View details →
Orphan

Avonex

Interferon beta-1a

Biogen, Inc.

1 INDICATIONS AND USAGE AVONEX is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome,

Pediatric multiple sclerosisNicolau syndromeNON RARE IN EUROPE: Multiple sclerosis
View details →
Orphan

Betaseron

Interferon beta-1b

Chiron Corp. & Berlex Laboratories

1 INDICATIONS AND USAGE BETASERON is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrom

NON RARE IN EUROPE: Multiple sclerosis
View details →
Orphan

Actimmune

Interferon gamma 1-b

Horizon Therapeutic Ireland DAC

1 INDICATIONS AND USAGE ACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Dis

Chronic granulomatous diseaseAutosomal recessive malignant osteopetrosis
View details →
Orphan

CARNEXIV

intravenous carbamazepine

Lundbeck LLC

Replacement therapy for oral carbamazepine formulations, when oral administration is temporarily not feasible, in adults with the following seizure ty

Epilepsy and/or ataxia with myoclonus as a major featureAutosomal recessive complex spastic paraplegiaMixed functioning pituitary adenomaEpilepsy with generalized tonic-clonic seizures alone
View details →
Orphan

AdreView

Iobenguane I 123

GE Healthcare, Inc.

1 INDICATIONS AND USAGE AdreView is a radiopharmaceutical agent for gamma-scintigraphy indicated for: use in the detection of primary or metastatic ph

EsthesioneuroblastomaView details →
Orphan

Azedra Ultratrace

Iobenguane I 131

Progenics Pharmaceuticals, Inc.

AZEDRA is indicated for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced

Neuroendocrine tumor of the rectumPineocytomaCarney-Stratakis syndrome
View details →

DATSCAN

IOFLUPANE I-123

Medi-Physics Inc. dba GE Healthcare.

View details →
Orphan

Yervoy

ipilimumab

Bristol-Myers Squibb Company

1 INDICATIONS AND USAGE YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for: Melanoma • Treatment of unresecta

Small cell lung cancerMalignant peritoneal mesotheliomaNON RARE IN EUROPE: Non-small cell lung cancer
View details →
Orphan⚠️ Black Box

FABHALTA

IPTACOPAN

Novartis Pharmaceuticals Corporation

1 INDICATIONS AND USAGE FABHALTA is a complement factor B inhibitor, indicated for: the treatment of adults with paroxysmal nocturnal hemoglobinuria (

C3 glomerulopathyParoxysmal nocturnal hemoglobinuriaImmunoglobulin A nephropathyIgA Nephropathy
View details →
Orphan⚠️ Black Box

Onivyde

irinotecan liposome injection

Ipsen Biopharmaceuticals, Inc.

1 INDICATIONS AND USAGE ONIVYDE is indicated, in combination with oxaliplatin, fluorouracil and leucovorin for the first-line treatment of adult patie

Familial pancreatic carcinomaRare carcinoma of pancreas
View details →
Orphan

Radiogardase

iron(III)-hexacyanoferrate(II)

Heyl Chemisch-Pharmzeutische Fabrik GMBH & Co, KG

1 INDICATIONS AND USAGE Radiogardase is indicated for treatment of patients with known or suspected internal contamination with radioactive cesium and

Systemic mastocytosis with associated hematologic neoplasmView details →
Orphan

Sarclisa

isatuximab-irfc

Sanofi-Aventis U.S. LLC

1 INDICATIONS AND USAGE SARCLISA is indicated: in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple m

Multiple myeloma
View details →
Orphan

Cresemba

isavuconazonium sulfate

Astellas Pharma Global Development Inc.

1 INDICATIONS AND USAGE CRESEMBA ® is an azole antifungal indicated for the treatment of: Invasive aspergillosis ( 1.1 ) and Invasive mucormycosis ( 1

Allergic bronchopulmonary aspergillosisZygomycosis
View details →
Orphan

CORLANOR

ivabradine

Amgen, Inc.,

1. INDICATIONS AND USAGE Corlanor (ivabradine) is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: To reduce the risk

Sensorineural deafness with dilated cardiomyopathyNON RARE IN EUROPE: Periventricular leukomalaciaFamilial dilated cardiomyopathy
View details →
Orphan

Kalydeco

IVACAFTOR

Vertex Pharmaceuticals Incorporated

1 INDICATIONS AND USAGE KALYDECO is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 month and older who have at least one mutat

Cystic fibrosis
View details →
Orphan⚠️ Black Box

Tibsovo

IVOSIDENIB

Servier Pharmaceutical LLC

1 INDICATIONS AND USAGE TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected

Acute megakaryoblastic leukemiaUnclassified myelodysplastic syndromeUnclassified acute myeloid leukemiaTherapy related acute myeloid leukemia and myelodysplastic syndromeCombined hepatocellular carcinoma and cholangiocarcinoma
View details →
Orphan

Ninlaro

ixazomib citrate

Takeda Development Center Americas, Inc.

1 INDICATIONS AND USAGE NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma wh

Multiple myeloma
View details →
Orphan

IXIARO

Japanese encephalitis vaccine, inactivated, adsorbed

Intercell AG

IXIARO is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus (JEV). IXIARO is approved for use in individuals 2 m

Japanese encephalitis
View details →

KETALAR

KETAMINE HYDROCHLORIDE

Par Health USA, LLC

1 INDICATIONS AND USAGE KETALAR (ketamine hydrochloride) injection is indicated: as the sole anesthetic agent for diagnostic and surgical procedures t

Lethal Larsen-like syndromeView details →
Orphan

L-Glutamine

L-GLUTAMINE

ANI Pharmaceuticals, Inc.

INDICATIONS For the temporary relief of mild abdominal pain or discomfort, diarrhea, minor joint pain, general weakness, muscle fatigue, sadness, or a

Gamma-glutamyl transpeptidase deficiencyView details →
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