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⚠️ Black Box

Votrient

pazopanib

Novartis Pharmaceuticals Corp

1 INDICATIONS AND USAGE VOTRIENT is a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC). ( 1.1 ) advanc

Alveolar soft tissue sarcomaRenal cell carcinoma
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Orphan

Adagen

Pegademase bovine

Sigma-tau Pharmaceuticals, Inc.

Short-limb skeletal dysplasia with severe combined immunodeficiency
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Orphan

Oncaspar; Asparlas

Pegaspargase

Servier Pharmaceuticals LLC

1 INDICATIONS AND USAGE ONCASPAR is an asparagine specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for treatment of

Acute lymphoblastic leukemia
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Orphan⚠️ Black Box

Empaveli

PEGCETACOPLAN

Apellis Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE EMPAVELI is a complement inhibitor indicated: for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PN

Paroxysmal nocturnal hemoglobinuriaC3 glomerulopathy
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Orphan

Neulasta

Pegfilgrastim

Amgen, Inc.

1 INDICATIONS AND USAGE ZIEXTENZO is a leukocyte growth factor indicated to • Decrease the incidence of infection, as manifested by febrile neutropeni

Difference of sex development of gynecological interestAcute radiation syndrome
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Orphan

Sylatron

peginterferon alfa-2b

Merck, Sharpe & Dohme Corp.

Adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphade

Malignant melanoma of the mucosaView details →
Orphan⚠️ Black Box

Krystexxa

pegloticase

Horizon Therapeutics Ireland DAC

1 INDICATIONS AND USAGE KRYSTEXXA ® (pegloticase) is indicated, for the treatment of chronic gout in adult patients refractory to conventional therapy

OBSOLETE: Limbic encephalitis with LGI1 antibodiesChronic mast cell leukemia
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Orphan⚠️ Black Box

ELFABRIO

PEGUNIGALSIDASE ALFA

Chiesi USA, Inc.

1 INDICATIONS AND USAGE ELFABRIO is indicated for the treatment of adults with confirmed Fabry disease. ELFABRIO is a hydrolytic lysosomal neutral gly

Fabry disease
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Orphan⚠️ Black Box

Palynziq

PEGVALIASE-PQPZ

BioMarin Pharmaceutical Inc.

1 INDICATIONS AND USAGE PALYNZIQ is indicated to reduce blood phenylalanine concentrations in adult and pediatric patients 12 years of age and older w

Maternal phenylketonuria syndromePhenylketonuria
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Orphan

Somavert

Pegvisomant

Sensus Corporation

1 INDICATIONS AND USAGE SOMAVERT is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation

Acromegaly
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Orphan⚠️ Black Box

Loargys

pegzilarginase-nbln

Immedica Pharma AB

1 INDICATIONS AND USAGE LOARGYS is indicated for the treatment of hyperargininemia in adult and pediatric patients 2 years of age and older with Argin

Argininemia
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Orphan

KEYTRUDA

pembrolizumab

MSD International Business GmbH

1 INDICATIONS AND USAGE KEYTRUDA QLEX is a combination of pembrolizumab, a programmed death receptor-1 (PD-1)-blocking antibody, and berahyaluronidase

Small cell lung cancerSquamous cell carcinoma of head and neckNON RARE IN EUROPE: Non-small cell lung cancerMalignant peritoneal mesothelioma
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KEYTRUDA QLEX

PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH

Merck Sharp & Dohme LLC

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Orphan

Alimta

pemetrexed disodium

Eli Lilly and Company

1 INDICATIONS AND USAGE ALIMTA ® is a folate analog metabolic inhibitor indicated: in combination with pembrolizumab and platinum chemotherapy, for th

Malignant peritoneal mesotheliomaNON RARE IN EUROPE: Non-small cell lung cancerSquamous cell carcinoma of pancreas
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Orphan

PEMAZYRE

Pemigatinib

Incyte Corporation

1 INDICATIONS AND USAGE PEMAZYRE is a kinase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced o

Cholangiocarcinoma
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Orphan⚠️ Black Box

Penicillamine

PENICILLAMINE

Endo USA, Inc.

INDICATIONS Penicillamine capsules are indicated in the treatment of Wilson's disease, cystinuria, and in patients with severe, active rheumatoid arth

Wilson diseaseCystinuriaJuvenile idiopathic arthritis
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Orphan

Nebupent

Pentamidine isethionate

Fujisawa USA, Inc.

INDICATIONS AND USAGE: NebuPent is indicated for the prevention of Pneumocystis jiroveci pneumonia (PJP) in high-risk, HIV-infected patients defined b

Lymphoid interstitial pneumoniaView details →
Orphan

Pentaspan

Pentastarch

DuPont Pharmaceuticals

Persistent left superior vena cava connecting to the roof of left-sided atrium
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Orphan

Elmiron

Pentosan polysulfate sodium

Alza Corporation

INDICATIONS AND USAGE ELMIRON ® (pentosan polysulfate sodium) is indicated for the relief of bladder pain or discomfort associated with interstitial c

Interstitial cystitis
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Orphan⚠️ Black Box

Nipent

pentostatin for injection

SuperGen, Inc.

INDICATIONS AND USAGE NIPENT is indicated as single-agent treatment for both untreated and alpha-interferon-refractory hairy cell leukemia patients wi

Classic hairy cell leukemia
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PERJETA

PERTUZUMAB

Genentech, Inc.

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Orphan⚠️ Black Box

TURALIO

pexidartinib

Daiichi Sankyo, Inc.

1 INDICATIONS AND USAGE TURALIO is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with

Tenosynovial giant cell tumor
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Orphan⚠️ Black Box

Sezaby

phenobarbital sodium

Sun Pharmaceutical Industries, Inc.

1 INDICATIONS AND USAGE SEZABY is indicated for the treatment of neonatal seizures in term and preterm infants. SEZABY is a barbiturate indicated for

Self-limited neonatal epilepsy
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Orphan⚠️ Black Box

PHYTONADIONE PHYTONADIONE

PHYTONADIONE

Dr.Reddy's Laboratories Inc

INDICATIONS AND USAGE Phytonadione injectable emulsion, USP is indicated in the following coagulation disorders which are due to faulty formation of f

Lymphoepithelial cyst of the pancreasHemolytic disease due to fetomaternal alloimmunizationMyopathic intestinal pseudoobstructionCongenital factor II deficiencyHypermethioninemia due to glycine N-methyltransferase deficiencyAcquired prothrombin deficiencyNON RARE IN EUROPE: Ulcerative colitisLemierre syndrome
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Orphan

Salagen

Pilocarpine

MGI Pharma, Inc.

INDICATIONS & USAGE SALAGEN ® Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiother

Recurrent Neisseria infections due to factor D deficiencyView details →
Orphan

Pirfenidone

PIRFENIDONE

AvKARE

1 INDICATIONS AND USAGE Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone is a pyridone indicat

Idiopathic pulmonary fibrosis
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Orphan

Pirfenidone Capsule, 267 Mg

PIRFENIDONE CAPSULE, 267 MG

Macleods Pharmaceuticals Limited

1 INDICATIONS AND USAGE Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone capsules are a pyrido

Idiopathic pulmonary fibrosis
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⚠️ Black Box

PIROXICAM

PIROXICAM

Unichem Pharmaceuticals (USA), Inc.

1 INDICATIONS AND USAGE Piroxicam capsules are indicated: • For relief of the signs and symptoms of osteoarthritis. • For relief of the signs and symp

Giant cell arteritisJuvenile idiopathic arthritis
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Orphan

Jaypirca

pirtobrutinib

Loxo Oncology, Inc.

1 INDICATIONS AND USAGE JAYPIRCA ® is a kinase inhibitor indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lympho

Mantle cell lymphoma
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Orphan

WAKIX

Pitolisant

Harmony Biosciences Management, Inc.

1 INDICATIONS AND USAGE WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older w

Narcolepsy
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