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

Chemet capsules

Succimer

Bock Pharmacal Company

1 INDICATIONS AND USAGE CHEMET is indicated for the treatment of lead poisoning in pediatric patients aged 1 year and older with blood lead levels abo

Fetal methylmercury syndromeView details →
Orphan

Enjaymo

SUTIMLIMAB-JOME

Recordati Rare Diseases, Inc.

1 INDICATIONS AND USAGE ENJAYMO is a classical complement inhibitor indicated for the treatment of hemolysis in adults with cold agglutinin disease (C

Neonatal autoimmune hemolytic anemiaCold agglutinin disease
View details →
Orphan

Chirostim

Synthetic human secretin

ChiRhoClin, Inc.

Stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction, stimulation of gastrin secret

OBSOLETE: Syndrome associated with Pierre Robin syndromeView details →
Orphan

Secreflo

Synthetic porcine secretin

ChiRhoClin, Inc.

Use in secretin stimulation testing for stimulation of gastrin secretion to aid in the diagnosis of gastrinoma ||| Use in secretin stimulation testing

OBSOLETE: Syndrome associated with Pierre Robin syndromeNeuroendocrine tumor of pancreasFamilial progressive hyper- and hypopigmentation
View details →
Orphan⚠️ Black Box

Envarsus XR

tacrolimus

Veloxis Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE ENVARSUS XR is a calcineurin-inhibitor immunosuppressant indicated for: The prophylaxis of organ rejection in de novo kidney t

Rare disorder potentially indicated for kidney transplant
View details →
Orphan⚠️ Black Box

Astagraf XL

tacrolimus extended-release capsules

Astellas Pharma Global Development, Inc.

1 INDICATIONS AND USAGE ASTAGRAF XL ® is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immu

Recurrent hepatitis C virus induced liver disease in liver transplant recipientsOBSOLETE: Rejection after corneal transplantation
View details →
Orphan

Tadalafil

TADALAFIL

Northwind Health Company, LLC

1 INDICATIONS AND USAGE Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO

Pulmonary arterial hypertension
View details →
Orphan

Vyndaqel

TAFAMIDIS MEGLUMINE

Pfizer Laboratories Div Pfizer Inc

1. INDICATIONS AND USAGE VYNDAQEL and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated

Wild type ATTR amyloidosisHereditary ATTR amyloidosisHereditary transthyretin-mediated amyloidosis
View details →
Orphan

MONJUVI

tafasitamab-cxix

Incyte Corporation

1 INDICATIONS AND USAGE MONJUVI is a CD19-directed cytolytic antibody indicated: in combination with lenalidomide for the treatment of adult patients

Diffuse large B-cell lymphomaFollicular lymphomaEpstein-Barr virus-positive diffuse large B-cell lymphoma
View details →
Orphan

Krintafel

tafenoquine

GlaxoSmithKline Intellectual Property Development Ltd. England

1 INDICATIONS AND USAGE KRINTAFEL is indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and

MalariaCystoid macular dystrophy
View details →
Orphan⚠️ Black Box

ELZONRIS

Tagraxofusp-erzs

Stemline Therapeutics, Inc.

1 INDICATIONS AND USAGE ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric pat

Blastic plasmacytoid dendritic cell neoplasm
View details →
Orphan

Ibtrozi

taletrectinib

Nuvation Bio Inc.

1 INDICATIONS AND USAGE IBTROZI ™ (taletrectinib) is indicated for the treatment of adult patients with locally advanced or metastatic ROS1 -positive

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

ELELYSO

TALIGLUCERASE ALFA

Pfizer Laboratories Div Pfizer Inc

1 INDICATIONS AND USAGE ELELYSO is indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of Type 1 Gaucher disea

Gaucher disease
View details →
Orphan

IMLYGIC

talimogene laherparepvec

BioVex, Inc. (subsidiary of Amgen)

1 INDICATIONS AND USAGE IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcuta

NON RARE IN EUROPE: Melanoma
View details →
Orphan⚠️ Black Box

Talvey

talquetamab-tgvs

Janssen Biotech, inc.

1 INDICATIONS AND USAGE TALVEY is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at leas

Multiple myeloma
View details →
Orphan⚠️ Black Box

Tamoxifen Citrate

TAMOXIFEN CITRATE

A-S Medication Solutions

INDICATIONS AND USAGE Metastatic Breast Cancer: Tamoxifen citrate tablets, USP are effective in the treatment of metastatic breast cancer in women and

Arterial dissection-lentiginosis syndromeRare malignant breast tumorAdrenocortical carcinoma
View details →
Orphan⚠️ Black Box

Imdelltra

tarlatamab-dlle

Amgen Inc.

1 INDICATIONS AND USAGE IMDELLTRA is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease

Small cell lung cancer
View details →
Orphan

HETLIOZ

tasimelteon

Vanda Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE HETLIOZ is a melatonin receptor agonist. HETLIOZ capsules are indicated for the treatment of: Non-24-Hour Sleep-Wake Disorder

Non-24-hour sleep-wake syndromeSmith-Magenis syndrome
View details →
Orphan

Tazverik

tazemetostat

Epizyme, Inc.

1 INDICATIONS AND USAGE TAZVERIK is a methyltransferase inhibitor indicated for the treatment of: Adults and pediatric patients aged 16 years and olde

Follicular lymphomaEpithelioid sarcoma
View details →
Orphan⚠️ Black Box

Kimmtrak

tebentafusp-tebn

Immunocore Ltd

1 INDICATIONS AND USAGE KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

Uveal melanoma
View details →
Orphan

LYMPHOSEEK

technetium Tc 99m tilmanocept

Cardinal Health 414, LLC

1 INDICATIONS AND USAGE Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for: • Lymphatic mapping using a

Squamous cell carcinoma of the oral cavity
View details →
Orphan

Technetium Tc99m Sulfur Colloi

Technetium Tc99m sulfur colloid injection, lyophilized

Pharmalucence, Inc.

Localization of lymph nodes draining a primary tumor in patients with melanoma when used with a hand-held gamma counter

Cholestatic pruritus in patients with Alagille syndrome (ALGS)View details →
Orphan⚠️ Black Box

Tecvayli

teclistamab-cqyv

Janssen Biotech, Inc.

1 INDICATIONS AND USAGE TECVAYLI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma in combination with dar

Multiple myeloma
View details →
Orphan

TPOXX

tecovirimat

SIGA Technologies, Inc.

1 INDICATIONS AND USAGE TPOXX is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein and is indicated for the treatment of human smallpox

Small bowel atresiaView details →
Orphan

GATTEX

teduglutide [rDNA origin]

Takeda Pharmaceuticals U.S.A., Inc.

1 INDICATIONS AND USAGE GATTEX ® is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SB

Primary short bowel syndrome
View details →
Orphan

Xermelo

telotristat etiprate

TerSera Therapeutics, LLC

1 INDICATIONS AND USAGE Xermelo is indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in

Middle ear neuroendocrine tumorCarcinoid syndrome
View details →
Orphan

Temodar

temozolomide

Schering-Plough Research Institute

1 INDICATIONS AND USAGE TEMODAR is an alkylating drug indicated for the treatment of adults with: Newly diagnosed glioblastoma concomitantly with radi

Giant cell glioblastoma
View details →
Orphan

Torisel

Temsirolimus

Wyeth Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE TORISEL is indicated for the treatment of advanced renal cell carcinoma. TORISEL ® is a kinase inhibitor indicated for the tre

Clear cell renal carcinomaRenal cell carcinoma
View details →
Orphan

Vumon for injection

Teniposide

Bristol-Myers Squibb Pharmaceutical Research Institute

Induction therapy in patients with refractory childhood acute lymphoblastic leukemia when used in combination with other approved anticancer agents.

Precursor T-cell acute lymphoblastic leukemia
View details →
Orphan⚠️ Black Box

Viread

tenofovir

Gilead Sciences, Inc.

1 INDICATIONS AND USAGE VIREAD is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicate

Congenital Epstein-Barr virus infectionChronic encephalitisZika virus disease
View details →
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