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.
Report missing data
💊

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.

IOPIDINE 1%

APRACLONIDINE HYDROCHLORIDE OPHTHALMIC SOLUTION

Harrow Eye, LLC

IOPIDINE 1% Ophthalmic Solution is indicated to control or prevent post-surgical elevations in IOP that occur in patients after argon laser trabeculop

X-linked complex spastic paraplegiaView details →
Orphan

OTEZLA�

apremilast

Amgen Inc.

1 INDICATIONS AND USAGE OTEZLA/OTEZLA XR, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: Adult patients with: Active p

Thomsen and Becker diseasePsoriasis-related juvenile idiopathic arthritisFilariasisPulmonary arterial hypertension associated with another disease
View details →
Orphan

Trasylol

Aprotinin

Bayer Corporation

View details →
Orphan

MIPLYFFA

ARIMOCLOMOL CITRATE

Acer Therapeutics Inc.

1 INDICATIONS AND USAGE MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick d

Niemann-Pick disease type C, adult neurologic onset
View details →
Orphan⚠️ Black Box

Abilify

aripiprazole

Otsuka Pharmaceutical Development

1 INDICATIONS AND USAGE ABILIFY (aripiprazole) Tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes a

NON RARE IN EUROPE: Tourette syndromeRare dystoniaOther dermis disorderChildhood-onset schizophreniaNijmegen breakage syndrome-like disorder
View details →
Orphan⚠️ Black Box

Trisenox

Arsenic trioxide

Teva Branded Pharmaceutical Products R&D, Inc.

1 INDICATIONS AND USAGE TRISENOX is an arsenical indicated: In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute

Acute promyelocytic leukemia
View details →
Orphan

Coartem

artemether/lumefantrine

Novartis Pharmaceuticals

1 INDICATIONS AND USAGE Coartem Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum (P. falcip

Recurrent Neisseria infections due to factor D deficiencyView details →
Orphan

Scemblix

asciminib

Novartis Pharmaceuticals Corporation

1 INDICATIONS AND USAGE SCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myelo

Chronic myeloid leukemiaB-lymphoblastic leukemia/lymphoma with t(9;22)(q34.1;q11.2)Acute myeloid leukemia with NPM1 somatic mutations
View details →
Orphan

Ascor

ascorbic acid

McGuff Pharmaceuticals Inc.

1. INDICATIONS AND USAGE ASCOR is vitamin C indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 mont

Atresia of urethraView details →

ASENAPINE

ASENAPINE

Sigmapharm Laboratories, LLC

View details →
Orphan⚠️ Black Box

Strensiq

ASFOTASE ALFA

Alexion Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE STRENSIQ ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). STR

Perinatal lethal hypophosphatasiaChildhood-onset hypophosphatasia
View details →
Orphan

Rylaze

asparaginase erwinia chrysanthemi (recombinant)-rywn

Jazz Pharmaceuticals Ireland Limited

1 INDICATIONS AND USAGE RYLAZE is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia

Acute lymphoblastic leukemiaPlasmablastic lymphoma
View details →
Orphan

TECENTRIQ

atezolizumab

Genentech, Inc.

1 INDICATIONS AND USAGE TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: Non-Small Cell Lung Cancer (NSCLC) as adjuvant t

Small cell lung cancerAlveolar soft tissue sarcoma
View details →
Orphan

Tecentriq and Avastin

atezolizumab + bevacizumab

Genentech, Inc.

TECENTRIQ, in combination with bevacizumab, for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not receiv

Adult hepatocellular carcinomaPediatric hepatocellular carcinoma
View details →
Orphan

Lenmeldy

ATIDARSAGENE AUTOTEMCEL

Orchard Therapeutics (Europe) Ltd

1 INDICATIONS AND USAGE LENMELDY is indicated for the treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile

Metachromatic leukodystrophy, late infantile form
View details →
Orphan

INMAZEB

atoltivimab, maftivimab, and odesivimab-ebgn

Regeneron Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE INMAZEB is indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, includ

Congenital enterovirus infectionView details →

MEPRON

ATOVAQUONE

GlaxoSmithKline LLC

1 INDICATIONS AND USAGE MEPRON oral suspension is a quinone antimicrobial drug indicated for: • Prevention of Pneumocystis jirovecii pneumonia (PCP) i

Pulmonary arterial hypertension associated with portal hypertensionHinman syndrome
View details →

MALARONE

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE

GlaxoSmithKline LLC

1 INDICATIONS AND USAGE MALARONE is an antimalarial indicated for: • prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquin

Primary anetodermaPlaque-form urticaria pigmentosa
View details →
Orphan⚠️ Black Box

Vanrafia

atrasentan

Novartis

1 INDICATIONS AND USAGE VANRAFIA is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid diseas

IgA NephropathyImmunoglobulin A nephropathy
View details →
Orphan

Tavneos

avacopan

ChemoCentryx, Inc.

1 INDICATIONS AND USAGE TAVNEOS is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody

Anti-neutrophil cytoplasmic antibody-associated vasculitisMicroscopic polyangiitisGranulomatosis with polyangiitis
View details →
Orphan⚠️ Black Box

Nexviazyme

AVALGLUCOSIDASE ALFA-NGPT

Genzyme Corporation

1 INDICATIONS AND USAGE NEXVIAZYME is indicated for the treatment of patients 1 year of age and older with late-onset Pompe disease (lysosomal acid al

Glycogen storage disease due to acid maltase deficiencyPompe disease
View details →
Orphan

Ayvakit

avapritinib

Blueprint Medicines Corporation

1 INDICATIONS AND USAGE AYVAKIT is a kinase inhibitor indicated for: Gastrointestinal Stromal Tumor (GIST) the treatment of adults with unresectable o

Gastrointestinal stromal tumorSystemic mastocytosisIndolent systemic mastocytosis
View details →
Orphan

Doptelet

avatrombopag

Sobi, Inc.

1 INDICATIONS AND USAGE DOPTELET is a thrombopoietin receptor agonist indicated for the treatment of: Thrombocytopenia in adult patients with chronic

Immune-mediated thrombotic thrombocytopenic purpuraWiskott-Aldrich syndromeImmune thrombocytopeniaAutoimmune thrombocytopenia
View details →
Orphan

Bavencio

avelumab (Recombinant human monoclonal IgG1 antibody against programmed death ligand-1)

EMD Serono Research and Development Institute, Inc.

1 INDICATIONS AND USAGE BAVENCIO is a programmed death ligand-1 (PD-L1) blocking antibody indicated for: Merkel Cell Carcinoma (MCC) Adults and pediat

Cutaneous neuroendocrine carcinomaRenal cell carcinomaMitochondrial DNA maintenance syndromeSquamous cell carcinoma of the rectum
View details →
Orphan

Avmapki Fakzynja Co-Pack

avutometinib; defactinib

Verastem, Inc.

1 INDICATIONS AND USAGE AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovaria

Hereditary breast and/or ovarian cancer syndromeHereditary site-specific ovarian cancer syndrome
View details →
Orphan

Niktimvo

axatilimab-csfr

Incyte Corporation

1 INDICATIONS AND USAGE NIKTIMVO is indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines

Chronic graft versus host disease
View details →
Orphan⚠️ Black Box

Yescarta

axicabtagene ciloleucel

Kite Pharma, Inc.

1 INDICATIONS AND USAGE YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patient

Follicular lymphomaPrimary vitreoretinal large B-cell lymphoma
View details →
Orphan

Azacitidine

AZACITIDINE

Dr. Reddy's Laboratories Inc.

1 INDICATIONS AND USAGE Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of: Adult patients with the followin

Myelodysplastic neoplasm with low blastsAcquired idiopathic sideroblastic anemiaMyelodysplastic neoplasm with increased blastsChronic myelomonocytic leukemia
View details →
Orphan

Azacitidine

AZACITIDINE FOR

Pilnova Pharma Inc

1 INDICATIONS AND USAGE Azacitidine for injection is a nucleoside metabolic inhibitor indicated for the treatment of: Adult patients with the followin

Chronic myelomonocytic leukemiaAcquired idiopathic sideroblastic anemiaMyelodysplastic neoplasm with increased blastsMyelodysplastic neoplasm with low blasts
View details →
Orphan

Azithromycin

AZITHROMYCIN

Preferred Pharmaceuticals Inc.

1 INDICATIONS AND USAGE Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused

Bacterial myositisAcquired neutropeniaNeuralgic amyotrophyCongenital Epstein-Barr virus infectionFollicular cholangitis and pancreatitisFetal Gaucher diseaseAcute endophthalmitisAngiostrongyliasis
View details →
← PreviousPage 3 of 32Next →

Find Additional Resources

🔬
Clinical Trials
Search recruiting trials for your condition
📖
Disease Library
Condition overviews with HPO annotations
🏥
Find Specialists
Treatment centers and rare disease experts
💊
Support Programs
Copay cards, grants, and patient assistance