FDA-Approved Treatments

Drugs with orphan designation or indications for rare diseases — 970 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

Tzield

teplizumab-mzwv

Provention Bio, Inc.

1 INDICATIONS AND USAGE TZIELD is indicated to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older wi

Early-onset obesity-hyperphagia-severe developmental delay syndromeView details →
Orphan

Tepmetko

tepotinib

EMD Serono, Inc.

1 INDICATIONS AND USAGE TEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesench

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

Parathar

Teriparatide

Rhone-Poulenc Rorer Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE Teriparatide injection is indicated: For the treatment of postmenopausal women with osteoporosis at high risk for fracture (de

NON RARE IN EUROPE: Chronic proteinuria with focal and segmental hyalinosisView details →
Orphan⚠️ Black Box

Terlivaz

terlipressin

Mallinckrodt Pharmaceuticals Ireland Ltd

1 INDICATIONS AND USAGE TERLIVAZ is indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function.

Zellweger syndromeView details →
Orphan⚠️ Black Box

Xenazine

tetrabenazine

Lundbeck

1 INDICATIONS AND USAGE XENAZINE is indicated for the treatment of chorea associated with Huntington’s disease. XENAZINE is a vesicular monoamine tran

Huntington's Disease
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Orphan

SYMDEKO

TEZACAFTOR AND IVACAFTOR

Vertex Pharmaceuticals Incorporated

1 INDICATIONS AND USAGE SYMDEKO is indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F

Cystic fibrosis
View details →
Orphan⚠️ Black Box

Thalomid

Thalidomide

Celgene Corporation

1 INDICATIONS AND USAGE • THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma

Teratoma of the central nervous systemMultiple myeloma
View details →
Orphan⚠️ Black Box

TEPADINA

THIOTEPA

Amneal Pharmaceuticals LLC

1 INDICATIONS AND USAGE TEPADINA (thiotepa) is an alkylating drug indicated: To reduce the risk of graft rejection when used in conjunction with high-

Rare adenocarcinoma of the breastMalignant peripheral nerve sheath tumor with perineurial differentiationSmall cell carcinoma of the bladderHemoglobin C-beta-thalassemia syndrome
View details →
Orphan

Thyrogen

Thyrotropin alfa

Genzyme Corporation

1 INDICATIONS AND USAGE THYROGEN ® is a thyroid stimulating hormone indicated for: Adjunctive Diagnostic Tool for Well-Differentiated Thyroid Cancer:

Well-differentiated papillary mesothelial tumour of the pleuraDifferentiated thyroid carcinoma
View details →
Orphan⚠️ Black Box

Tindamax

Tinidazole

Presutti Laboratories, Inc.

1 INDICATIONS AND USAGE 1 INDICATIONS AND USAGE 1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas v

Testicular teratomaView details →
Orphan

Thiola

Tiopronin

Mission Pharmacal Company

1 INDICATIONS AND USAGE THIOLA EC is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine st

Homocystinuria due to cystathionine beta-synthase deficiencyView details →
Orphan⚠️ Black Box

Kymriah

tisagenlecleucel

Novartis Pharmaceuticals Corporation

1 INDICATIONS AND USAGE KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Patients up to

Follicular lymphomaEpstein-Barr virus-positive diffuse large B-cell lymphomaPrecursor T-cell acute lymphoblastic leukemiaALK-positive large B-cell lymphoma
View details →
Orphan

Tevimbra

tislelizumab-jsgr

BeOne Medicines USA, Inc.

1 INDICATIONS AND USAGE TEVIMBRA is a programmed death receptor-1 (PD-1)-blocking antibody indicated for: Esophageal Cancer in combination with platin

Adenocarcinoma of the oesophagus and oesophagogastric junctionSquamous cell carcinoma of the esophagus
View details →
Orphan

TOBRAMYCIN

TOBRAMYCIN

Aurobindo Pharma Limited

1 INDICATIONS AND USAGE Tobramycin inhalation solution is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of

Thoracic outlet syndromeView details →

TOBRADEX ST

TOBRAMYCIN / DEXAMETHASONE

Harrow Eye, LLC

1 INDICATIONS AND USAGE TOBRADEX ST ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroi

Anterior uveitisCongenital retinal arteriovenous communicationTransposition of the great arteries and conotruncal cardiac anomalyCongenital vitamin K-dependent coagulation factors deficiencyChronic relapsing inflammatory optic neuritisRare disorder of the anterior segment of the eyeAutoinflammatory syndrome with pyogenic bacterial infection and amylopectinosis
View details →
Orphan

TOBI

Tobramycin for inhalation

Mylan Specialty LP

1 INDICATIONS AND USAGE TOBI is indicated for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudom

Pneumonia caused by Pseudomonas aeruginosa infectionView details →
Orphan⚠️ Black Box

Actemra

tocilizumab

Genentech, Inc.

1 INDICATIONS AND USAGE ACTEMRA ® (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA) (

Rheumatoid factor-positive polyarticular juvenile idiopathic arthritisSystemic-onset juvenile idiopathic arthritisExposure-related interstitial lung diseasePolyarticular juvenile idiopathic arthritisCogan-Reese syndromeNipah virus diseaseJuvenile idiopathic arthritisGiant cell arteritis
View details →
Orphan

Qalsody

tofersen

Biogen Inc.

1 INDICATIONS AND USAGE QALSODY is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide

Amyotrophic Lateral Sclerosis (ALS)
View details →
Orphan⚠️ Black Box

Jynarque

tolvaptan

Otsuka Pharmaceutical Company, Ltd.

1 INDICATIONS AND USAGE JYNARQUE is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic k

Autosomal dominant polycystic kidney disease
View details →
Orphan

Topamax

Topiramate

Johnson & Johnson Pharmaceutical R & D, LLC

1 INDICATIONS AND USAGE TOPAMAX is indicated for: Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic

Lennox-Gastaut syndromeEating reflex epilepsyEpilepsy with generalized tonic-clonic seizures alone
View details →
Orphan⚠️ Black Box

Fareston

Toremifene

Orion Corporation

1 INDICATIONS AND USAGE FARESTON® is an estrogen agonist/antagonist indicated for the treatment of metastatic breast cancer in postmenopausal women wi

Metaplastic carcinoma of the breastRare malignant breast tumor
View details →
Orphan

Loqtorzi

toripalimab-tpzi

Coherus BioSciences, Inc.

1 INDICATIONS AND USAGE LOQTORZI is a programmed death receptor-1 (PD-1)- blocking antibody indicated: in combination with cisplatin and gemcitabine,

Nasopharyngeal carcinoma
View details →
Orphan

Bexxar

Tositumomab and iodine I 131 tositumomab

GlaxoSmithKline LLC

Treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to Rituxima

T-cell non-Hodgkin lymphomaComposite lymphoma
View details →
Orphan

Ojemda

tovorafenib

Day One Biopharmaceuticals, Inc.

1 INDICATIONS AND USAGE OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade gl

Pilocytic astrocytoma
View details →
Orphan

Yondelis

trabectedin

Janssen Research & Development, LLC

1 INDICATIONS AND USAGE YONDELIS ® is indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who

Alveolar soft tissue sarcomaPleomorphic liposarcoma
View details →
Orphan

MEKINIST

trametinib

Novartis Pharmaceuticals Corp.

1 INDICATIONS AND USAGE MEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with u

NON RARE IN EUROPE: Non-small cell lung cancerAdult-onset distal myopathy due to VCP mutationFragile X-associated primary ovarian insufficiencyLaminopathy with striated muscle involvementCongenitally uncorrected transposition of the great arteries with coarctation
View details →
Orphan

MEKINIST and TAFINLAR

trametinib and dabrafenib

Novartis Pharmaceuticals Corporation

TAFINLAR is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as det

NON RARE IN EUROPE: MelanomaPerry syndromeAdult-onset distal myopathy due to VCP mutation
View details →
Orphan

tranexamic acid

TRANEXAMIC ACID

Avenacy, Inc.

1 INDICATIONS AND USAGE Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent

Hemophilia
View details →
Orphan⚠️ Black Box

Herceptin

trastuzumab

Genentech, Inc.

1 INDICATIONS AND USAGE Herceptin is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2-overexpressing breast cancer. ( 1.1

Adenocarcinoma of the oesophagus and oesophagogastric junctionHereditary breast cancerHereditary diffuse gastric cancer
View details →
Orphan

Imjudo

tremelimumab-actl

AstraZeneca Pharmaceuticals LP

1 INDICATIONS AND USAGE IMJUDO is a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody indicated: • in combination with durvalumab

Adult hepatocellular carcinomaSmall cell lung cancer
View details →
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