FDA-Approved Treatments

Drugs with orphan designation or indications for rare diseases — 968 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

Tryngolza

olezarsen

Ionis Pharmaceuticals

1 INDICATIONS AND USAGE TRYNGOLZA is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). T

Familial chylomicronemia syndrome
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Orphan⚠️ Black Box

XENPOZYME

OLIPUDASE ALFA-RPCP

Genzyme Corporation

1 INDICATIONS AND USAGE XENPOZYME is indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) i

Acid sphingomyelinase deficiency
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OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

Ascend Laboratories, LLC

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Orphan⚠️ Black Box

Rezlidhia

olutasidenib

Rigel Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE Relapsed or Refractory Acute Myeloid Leukemia REZLIDHIA is indicated for the treatment of adult patients with relapsed or refr

Acute myeloid leukemiaAcute myeloid leukemia with NPM1 somatic mutations
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Orphan

Synribo

omacetaxine mepesuccinate

IVAX International GmbH

Treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosin

Chronic myeloid leukemiaAcute myeloid leukemia and myelodysplastic syndromes related to topoisomerase type 2 inhibitor
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Orphan

Skyclarys

omaveloxolone

Biogen U.S. Corporation

1 INDICATIONS AND USAGE SKYCLARYS is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older. SKYCLARYS i

Friedreich ataxia
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Orphan

Omeprazole

OMEPRAZOLE

PD-Rx Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE Omeprazole is a proton pump inhibitor (PPI) indicated for the: • Treatment of active duodenal ulcer in adults (1.1) • Eradicat

Genetic gastro-esophageal diseaseIdiopathic hypersomniaRare bacterial infectious diseaseGlycogen storage disease due to acid maltase deficiencyAcute adrenal insufficiencyRare benign breast tumor
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Orphan⚠️ Black Box

Omisirge

OMIDUBICEL-ONLV

Gamida Cell Inc.

1 INDICATIONS AND USAGE OMISIRGE is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for the

Rare disorder potentially indicated for hematopoietic stem cell transplantRare hematologic diseaseRare aplastic anemia
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Orphan⚠️ Black Box

ITVISMA

ONASEMNOGENE ABEPARVOVEC-BRVE

Novartis Gene Therapies, Inc.

1 INDICATIONS AND USAGE ITVISMA is indicated for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and old

Distal hereditary motor neuropathy
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Orphan⚠️ Black Box

Zolgensma

ONASEMNOGENE ABEPARVOVEC-XIOI

Novartis Gene Therapies, Inc.

1 INDICATIONS AND USAGE ZOLGENSMA is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of pediatric patients less

Spinal Muscular AtrophyDistal hereditary motor neuropathy
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ONDANSETRON

ONDANSETRON

West-Ward Pharmaceuticals Corp

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ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE

Onesource Specialty Pharma Limited

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Orphan

Neumega

Oprelvekin

Genetics Institute, Inc.

Autoimmune heparin-induced thrombocytopeniaView details →

FOUNDAYO

ORFORGLIPRON

Eli Lilly and Company

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ALLI

ORLISTAT

Haleon US Holdings LLC

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Orphan

Isturisa

osilodrostat

Recordati Rare Diseases, Inc

1 INDICATIONS AND USAGE ISTURISA is indicated for the treatment of endogenous hypercortisolemia in adults with Cushing's syndrome for whom surgery is

Cushing diseaseLeigh syndrome with nephrotic syndrome
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Orphan

Tagrisso

osimertinib

AstraZeneca Pharmaceuticals LP

1 INDICATIONS AND USAGE TAGRISSO is a kinase inhibitor indicated for: • adjuvant therapy after tumor resection in adult patients with non-small cell l

NON RARE IN EUROPE: Non-small cell lung cancerSmall cell lung cancerSquamous cell carcinoma of gallbladder and extrahepatic biliary tract
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⚠️ Black Box

OXALIPLATIN

OXALIPLATIN

Accord Healthcare Inc.

1 INDICATIONS AND USAGE Oxaliplatin Injection, in combination with infusional fluorouracil and leucovorin, is indicated for: adjuvant treatment of sta

Familial colorectal cancer Type XRare otorhinolaryngologic tumor
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Orphan⚠️ Black Box

Taxol

Paclitaxel

Bristol-Myers Squibb Pharmaceutical Research Institute

INDICATIONS AND USAGE Paclitaxel Injection, USP is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line

Small cell carcinoma of the ovaryRare malignant breast tumorSmall cell lung cancer
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Orphan⚠️ Black Box

Abraxane

paclitaxel protein-bound particles

Abraxis BioScience, LLC

1 INDICATIONS AND USAGE ABRAXANE is a microtubule inhibitor indicated for the treatment of: • Metastatic breast cancer, after failure of combination c

Familial atypical multiple mole melanoma syndromeRare malignant breast tumorSmall cell lung cancerMetaplastic carcinoma of the breastAdenocarcinoma of the penis
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Orphan

Vonjo

PACRITINIB

Sobi, Inc.

1 INDICATIONS AND USAGE VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or

OBSOLETE: Inherited predisposition to essential thrombocythemiaAcquired secondary polycythemiaPrimary myelofibrosis
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Orphan

Cytalux

pafolacianine

On Target Laboratories, LLC

1. INDICATIONS AND USAGE CYTALUX is indicated as an adjunct for intraoperative identification of: Malignant lesions in adult patients with ovarian can

OBSOLETE: Blepharophimosis-epicanthus inversus-ptosis due to copy number variationsView details →
Orphan

Yorvipath

palopegteriparatide

Ascendis Pharma Bone Diseases A/S

1 INDICATIONS AND USAGE YORVIPATH is indicated for the treatment of hypoparathyroidism in adults. YORVIPATH is a parathyroid hormone analog (PTH(1-34)

Rare hypoparathyroidism
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Orphan⚠️ Black Box

Sohonos

PALOVAROTENE

Ipsen Biopharmaceuticals, Inc.

1 INDICATIONS AND USAGE SOHONOS is indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years

Fibrodysplasia ossificans progressiva
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Orphan

Palsonify

paltusotine

Crinetics Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE PALSONIFY is indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom s

Acromegaly
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Orphan

Farydak

panobinostat

zr pharma& GmbH

FARYDAK (panobinostat) in combination with bortezomib (BTZ) and dexamethasone (DEX) for the treatment of patients with multiple myeloma who have recei

Multiple myeloma
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Orphan⚠️ Black Box

Natpara

parathyroid hormone

Takeda Pharmaceuticals U.S.A., Inc.

1 INDICATIONS AND USAGE NATPARA is a parathyroid hormone indicated as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hyp

Rare hypoparathyroidismBartter syndrome with hypocalcemia
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Orphan

Zemplar

paricalcitol

Abbvie, inc.

1 INDICATIONS AND USAGE ZEMPLAR is a vitamin D analog indicated in adults and pediatric patients 10 years and older for the prevention and treatment o

Genetic hyperparathyroidismPulmonary arterial hypertension associated with chronic hemolytic anemiaSecondary interstitial lung disease specific to adulthood associated with a systemic disease
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Orphan

Signifor

pasireotide

Novartis Pharmaceuticals Corporation

1 INDICATIONS AND USAGE SIGNIFOR is a somatostatin analog indicated for the treatment of adult patients with Cushing's disease for whom pituitary surg

Cushing disease
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Orphan

Onpattro

PATISIRAN

Alnylam Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE ONPATTRO is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. ONPA

Hereditary transthyretin-mediated amyloidosisHereditary ATTR amyloidosis
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