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

Phos-Lo

Calcium acetate

Fresenius Medical Care North America

1 INDICATIONS AND USAGE Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Ca

Hyperphosphatasia-intellectual disability syndromeView details →
Orphan⚠️ Black Box

Xywav

calcium, magnesium, potassium, and sodium oxybates

Jazz Pharmaceuticals Ireland Limited

1 INDICATIONS AND USAGE XYWAV is a central nervous system depressant indicated for the treatment of: • Cataplexy or excessive daytime sleepiness (EDS)

NarcolepsyIdiopathic hypersomnia
View details →
Orphan

Infasurf

calfactant

ONY Biotech Inc.

1 INDICATIONS AND USAGE INFASURF is indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates <29 weeks of gestational

Neonatal acute respiratory distress syndromeInfant acute respiratory distress syndrome
View details →
Orphan

ILARIS

canakinumab

Novartis Pharmaceuticals Corporation

1 INDICATIONS AND USAGE ILARIS is an interleukin-1β blocker indicated for the treatment of: • Periodic Fever Syndromes ( 1.1 ): - Cryopyrin-Associated

Familial Mediterranean feverNLRP3-associated autoinflammatory diseaseMuckle-Wells syndromeHyperimmunoglobulinemia D with periodic feverAdult-onset Still diseaseSystemic-onset juvenile idiopathic arthritisUndifferentiated carcinoma with osteoclast-like giant cells of pancreasFamilial cold urticariaTumor necrosis factor receptor 1 associated periodic syndrome
View details →
Orphan

Epidiolex

CANNABIDIOL

Jazz Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or t

Lennox-Gastaut syndromeDravet syndromeTuberous sclerosis complex
View details →
Orphan

Cablivi

CAPLACIZUMAB

Genzyme Corporation

1 INDICATIONS AND USAGE CABLIVI is indicated for the treatment of adult and pediatric patients 12 years of age and older with acquired thrombotic thro

Thrombotic thrombocytopenic purpuraImmune-mediated thrombotic thrombocytopenic purpura
View details →
Orphan

Qutenza

capsaicin

Averitas Pharma, Inc.

1 INDICATIONS AND USAGE QUTENZA is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and for neur

NON RARE IN EUROPE: Post-herpetic neuralgia
View details →
⚠️ Black Box

CARBAMAZEPINE

CARBAMAZEPINE

Alembic Pharmaceuticals Inc.

INDICATIONS AND USAGE Epilepsy Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an antic

Trigeminal neuralgiaGlossopharyngeal neuralgiaAtypical hemolytic uremic syndrome with complement gene abnormalityEpilepsy with generalized tonic-clonic seizures aloneMixed functioning pituitary adenoma
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DUOPA

CARBIDOPA AND LEVODOPA

AbbVie Inc.

1 INDICATIONS AND USAGE DUOPA ® is indicated for the treatment of motor fluctuations in patients with advanced Parkinson’s disease. DUOPA is a combina

Prader-Willi-like syndromeView details →

DHIVY

CARBIDOPA LEVODOPA

Avion Pharmaceuticals, LLC

1 INDICATIONS AND USAGE DHIVY is indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that

Dystonia-parkinsonism-hypermanganesemia syndromeX-linked reticulate pigmentary disorderPostencephalitic parkinsonismRare parkinsonian syndrome due to intoxication
View details →

CARBIDOPA, LEVODOPA, AND ENTACAPONE

CARBIDOPA, LEVODOPA, AND ENTACAPONE

Sandoz Inc

1 INDICATIONS AND USAGE Carbidopa, levodopa and entacapone tablets, are indicated for the treatment of Parkinson’s disease. Carbidopa, levodopa and en

OBSOLETE: Levodopa-unresponsive juvenile parkinsonismView details →
Orphan

Kyprolis

carfilzomib

Onyx Therapeutics, Inc.

1 INDICATIONS AND USAGE Kyprolis is a proteasome inhibitor that is indicated: for the treatment of adult patients with relapsed or refractory multiple

Multiple myeloma
View details →
Orphan

Carbaglu

CARGLUMIC ACID

Recordati Rare Diseases

1. INDICATIONS AND USAGE CARBAGLU is a carbamoyl phosphate synthetase 1 (CPS 1) activator indicated in pediatric and adult patients as: Adjunctive the

Hyperammonemia due to N-acetylglutamate synthase deficiency
View details →
Orphan

AMONDYS 45

CASIMERSEN

Sarepta Therapeutics, Inc.

1 INDICATIONS AND USAGE AMONDYS 45 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of th

Duchenne muscular dystrophy
View details →
Orphan

Inqovi

CEDAZURIDINE AND DECITABINE

Taiho Pharmaceutical Co., Ltd.

1 INDICATIONS AND USAGE INQOVI is indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and unt

Juvenile myelomonocytic leukemiaMyelodysplastic syndrome
View details →

CEFEPIME HYDROCHLORIDE AND DEXTROSE

CEFEPIME HYDROCHLORIDE

B. Braun Medical Inc.

View details →
Orphan

Oxervate

cenegermin-bkbj

Dompe S.p.A.

1 INDICATIONS AND USAGE OXERVATE ® (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis. OXERVATE is

Neurotrophic keratopathy
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Orphan

Anascorp

Centruroides immune F(ab)2

Rare Disease Therapeutics, Inc.

Treatment of clinical signs of scorpion envenomation

Scorpion envenomation
View details →
Orphan

ZYKADIA

ceritinib

Novartis Pharmaceuticals Corp.

1 INDICATIONS AND USAGE ZYKADIA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are

NON RARE IN EUROPE: Non-small cell lung cancer
View details →
Orphan⚠️ Black Box

Brineura

CERLIPONASE ALFA

BioMarin Pharmaceutical Inc.

1 INDICATIONS AND USAGE BRINEURA is indicated to slow the loss of ambulation in pediatric patients with neuronal ceroid lipofuscinosis type 2 (CLN2 di

CLN2 disease
View details →

ZYRTEC

CETIRIZINE HYDROCHLORIDE

Kenvue Brands LLC

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the

X-linked Ehlers-Danlos syndromeView details →
Orphan⚠️ Black Box

Erbitux

cetuximab

ImClone Systems Incorporated

1 INDICATIONS AND USAGE ERBITUX ® is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer Locally or

Squamous cell carcinoma of liver and intrahepatic biliary tractFamilial progressive retinal dystrophy-iris coloboma-congenital cataract syndromeFamilial colorectal cancer Type XNON RARE IN EUROPE: Colorectal cancerHereditary nonpolyposis colon cancerSquamous cell carcinoma of head and neck
View details →
Orphan

Chenix

chenodiol

Solvay

1 INDICATIONS AND USAGE CTEXLI is indicated for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. CTEXLI is a bile acid indicated for t

OBSOLETE: IFNG-responsive severe mendelian susceptibility to mycobacterial diseases
View details →

CHLORPROMAZINE HYDROCHLORIDE

CHLORPROMAZINE HYDROCHLORIDE

Saptalis Pharmaceuticals, LLC.

View details →
Orphan

Cholbam

CHOLIC ACID

Mirum Pharmaceuticals Inc.

1 INDICATIONS AND USAGE CHOLBAM is a bile acid indicated for: • Treatment of bile acid synthesis disorders due to single enzyme defects (SEDs). ( 1.1

Rare inborn errors of metabolismCongenital intestinal disease due to an enzymatic defectPeroxisome biogenesis disorder
View details →
Orphan⚠️ Black Box

Carvykti

ciltacabtagene autoleucel

Janssen Research & Development, LLC

1 INDICATIONS AND USAGE CARVYKTI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at l

Multiple myeloma
View details →
Orphan

Cimetidine

CIMETIDINE

Chartwell RX, LLC

INDICATIONS AND USAGE Cimetidine tablets are indicated in: 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and the

Multiple endocrine neoplasiaZollinger-Ellison syndromeSystemic mastocytosisNeuroendocrine tumor of stomachGastric linitis plasticaDuodenal atresiaCongenital sucrase-isomaltase deficiencyRare gastroesophageal disease
View details →

CINACALCET

CINACALCET

Aurobindo Pharma Limited

1 INDICATIONS AND USAGE Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult

Familial primary hyperparathyroidismAutoimmune polyendocrinopathy type 1Parathyroid carcinoma
View details →
Orphan⚠️ Black Box

POMBILITI ATGA

CIPAGLUCOSIDASE ALFA-ATGA

AMICUS THERAPEUTICS US, LLC

1 INDICATIONS AND USAGE POMBILITI is indicated, in combination with Opfolda, for the treatment of adult patients with late-onset Pompe disease (lysoso

Pompe disease
View details →
Orphan

Pombiliti and Opfolda

cipaglucosidase alfa-atga and miglustat

Amicus Therapeutics, Inc.

in combination with Pombiliti, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) w

Glycogen storage disease due to acid maltase deficiency
View details →
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