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

Ryplazim

plasminogen, human-tvmh

ProMetic BioTherapeutics, Inc.

Treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia).

Tyrosinemia type 2Hypoplasminogenemia
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Orphan

Mozobil

plerixafor

Genzyme Corporation

1 INDICATIONS AND USAGE Mozobil is indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for co

Multiple myeloma
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Orphan

Redemplo

plozasiran

Arrowhead Pharmaceuticals, Inc.

as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS)

Familial chylomicronemia syndrome
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POLIVY

POLATUZUMAB VEDOTIN

Genentech, Inc.

1 INDICATIONS AND USAGE POLIVY is a CD79b-directed antibody and microtubule inhibitor conjugate indicated: in combination with a rituximab product, cy

Primary cutaneous peripheral T-cell lymphoma not otherwise specifiedEpstein-Barr virus-positive diffuse large B-cell lymphoma
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Orphan

Gliadel

polifeprosan 20 with carmustine

Guilford Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE GLIADEL Wafer is indicated for the treatment of patients with: newly-diagnosed high-grade glioma as an adjunct to surgery and

Rare ovarian cancerHigh-grade astrocytomaRetinoblastoma
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Orphan⚠️ Black Box

POMALYST�

pomalidomide

Celgene Corporation

1 INDICATIONS AND USAGE Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: in combination with dexamethas

Kaposi sarcomaOBSOLETE: HIV-related Kaposi sarcomaMultiple myeloma
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Orphan⚠️ Black Box

Iclusig

ponatinib

Takeda Pharmaceuticals U.S.A., Inc.

1 INDICATIONS AND USAGE ICLUSIG ® is indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Precursor T-cell acute lymphoblastic leukemiaChronic myeloid leukemia
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Orphan

Photofrin

porfimer

Axcan Scandipharm Inc.

1 INDICATIONS AND USAGE PHOTOFRIN is a photoactivated radical generator indicated for: Esophageal Cancer ( 1.1 ) Palliation of patients with completel

High-grade dysplasia in patients with Barrett esophagusNeuroendocrine neoplasm of esophagusNON RARE IN EUROPE: Non-small cell lung cancer
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Orphan

Noxafil

posaconazole

Merck Sharp & Dohme LLC

1 INDICATIONS AND USAGE Noxafil is an azole antifungal indicated as follows: Noxafil is indicated for the treatment of invasive aspergillosis as follo

Allergic bronchopulmonary aspergillosis
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Orphan

Urocit-K

Potassium citrate

University of Texas Health Science Center at Dallas

1 INDICATIONS AND USAGE 1.1 Renal Tubular Acidosis (RTA) with Calcium Stones Potassium citrate is indicated for the management of renal tubular acidos

Distal renal tubular acidosis with anemia
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Orphan

ThyroShield

Potassium Iodide Oral Solution

Fleming & Company, Pharmaceuticals

For use as a thyroid blocking agent in pediatric patients exposed to radiactive iodine

Acute myeloid leukemia and myelodysplastic syndromes related to radiationView details →
Orphan⚠️ Black Box

Veopoz

pozelimab-bbfg

Regeneron Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE VEOPOZ is indicated for the treatment of adult and pediatric patients 1 year of age and older with CD55-deficient protein-losi

Complement hyperactivation-angiopathic thrombosis-protein-losing enteropathy syndrome
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Orphan

Zevaskyn

PRADEMAGENE ZAMIKERACEL

Abeona Therapeutics Inc.

1 INDICATIONS AND USAGE ZEVASKYN is indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bull

Dystrophic epidermolysis bullosa
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Orphan

Folotyn

pralatrexate

Acrotech Biopharma LLC

1 INDICATIONS AND USAGE FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indicat

Primary cutaneous peripheral T-cell lymphoma not otherwise specified
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Orphan

Protopam Chloride

PRALIDOXIME CHLORIDE

Baxter Healthcare Corporation

INDICATIONS AND USAGE PROTOPAM Chloride is indicated as an antidote: 1. In the treatment of poisoning due to those pesticides and chemicals (e.g., ner

Manganese poisoningJuvenile myasthenia gravis
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Orphan⚠️ Black Box

GAVRETO�

pralsetinib

Rigel Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE GAVRETO is a kinase inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET )

MITF-related melanoma and renal cell carcinoma predisposition syndromeCancer-associated retinopathyNON RARE IN EUROPE: Non-small cell lung cancer
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Orphan

Prednisolone

PREDNISOLONE

Aurobindo Pharma Limited

INDICATIONS AND USAGE 1. Endocrine disorders . Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; syn

View details →
Orphan

Prednisolone Sodium Phosphate

PREDNISOLONE SODIUM PHOSPHATE

Proficient Rx LP

INDICATIONS AND USAGE Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5 mL) is indicated in the following conditions: 1. Allergic

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Orphan

Prednisone

PREDNISONE

A-S Medication Solutions

INDICATIONS Prednisone tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hy

View details →
Orphan

Pretomanid

Pretomanid

Global Alliance for TB Drug Development

1 INDICATIONS AND USAGE Limited Population: Pretomanid Tablet is indicated, as part of a combination regimen with bedaquiline and linezolid for the tr

Primary genito-urinary tuberculosisView details →

PROCHLORPERAZINE EDISYLATE

PROCHLORPERAZINE EDISYLATE

Somerset Therapeutics, LLC

View details →
Orphan

HEMANGEOL

propranolol

Eton Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE HEMANGEOL oral solution contains the beta-adrenergic blocker propranolol hydrochloride and is indicated for the treatment of p

OBSOLETE: Infantile non-syndromic cataractView details →
Orphan

Ceprotin

Protein C concentrate

Baxalta US, Inc.

Prevention and treatment of venous thrombosis and purpura fulminans

KIAA1109-related early lethal congenital brain malformations-arthrogryposis syndromeView details →
Orphan

Kcentra

prothrombin complex concentrate (human)

CSL Behring

Urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute m

Disorder of vitamin and non-protein cofactor absorption and transportView details →
Orphan

Balfaxar

prothrombin complex concentrate, human-lans

Octapharma USA, Inc.

urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need fo

Laryngo-onycho-cutaneous syndromeView details →
Orphan

Curosurf

Pulmonary surfactant replacement, porcine

Chiesi USA, Inc.

1 INDICATIONS AND USAGE CUROSURF ® (poractant alfa) Intratracheal Suspension is indicated for the rescue treatment of Respiratory Distress Syndrome (R

Infant acute respiratory distress syndrome
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Orphan

Pyridostigmine Bromide

PYRIDOSTIGMINE BROMIDE

ANI Pharmaceuticals, Inc.

INDICATIONS AND USAGE Pyridostigmine Bromide Tablets USP are useful in the treatment of myasthenia gravis.

Myasthenia gravis
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Orphan

Pyridostigmine

PYRIDOSTIGMINE BROMIDE ORAL

Novitium Pharma LLC

INDICATIONS & USAGE Pyridostigmine Bromide Oral Solution, USP is useful in the treatment of myasthenia gravis.

Myasthenia gravis
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QUETIAPINE FUMARATE

QUETIAPINE FUMARATE

Accord Healthcare Inc.

View details →
Orphan⚠️ Black Box

Vanflyta

quizartinib

Daiichi Sankyo, Inc.

1 INDICATIONS AND USAGE VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as

Acute myeloid leukemia
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