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

Raloxifene Hydrochloride

RALOXIFENE

Aphena Pharma Solutions - Tennessee, LLC

1 INDICATIONS AND USAGE Raloxifene hydrochloride tablet, USP is an estrogen agonist/ antagonist indicated for: Treatment and prevention of osteoporosi

Osteoporosis-oculocutaneous hypopigmentation syndromeInvasive scopulariopsis infection
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Orphan⚠️ Black Box

Raloxifene Hydrochloride

RALOXIFENE HYDROCHLORIDE

NorthStar Rx LLC

1 INDICATIONS AND USAGE Raloxifene hydrochloride is an estrogen agonist/antagonist indicated for: Treatment and prevention of osteoporosis in postmeno

Invasive scopulariopsis infectionOsteoporosis-oculocutaneous hypopigmentation syndrome
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RAMELTEON

RAMELTEON

Micro Labs Limited

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Orphan

CYRAMZA

ramucirumab

Eli Lilly and Company

1 INDICATIONS AND USAGE CYRAMZA ® is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated: as a single agent or in comb

Hereditary gastric cancerSquamous cell carcinoma of the esophagusAdenocarcinoma of ovarySmall cell lung cancerHereditary nonpolyposis colon cancerHepatocellular carcinoma
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BYOOVIZ

RANIBIZUMAB-NUNA

BIOGEN INC.

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Orphan

Ranitidine

RANITIDINE

Rising Pharma Holdings, Inc.

Use(s) relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach broug

Pulmonary arterial hypertension associated with HIV infectionScorpion envenomation
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Orphan⚠️ Black Box

Elitek

rasburicase

Sanofi-Synthelabo Research

1 INDICATIONS AND USAGE Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymph

REN-related autosomal dominant tubulointerstitial kidney diseaseAcute erythroid leukemiaLymphomaTrehalase deficiency
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Orphan⚠️ Black Box

Ultomiris

RAVULIZUMAB

Alexion Pharmaceuticals Inc.

1 INDICATIONS AND USAGE ULTOMIRIS is a complement inhibitor indicated for: the treatment of adult and pediatric patients one month of age and older wi

Paroxysmal nocturnal hemoglobinuriaNeuromyelitis optica spectrum disorderTransient neonatal myasthenia gravisAtypical hemolytic uremic syndrome
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Orphan⚠️ Black Box

ABthraxTM

raxibacumab

Human Genome Sciences, Inc.

1 INDICATIONS AND USAGE Raxibacumab is indicated for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis

Inhalational anthrax
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Orphan

Idelvion

recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)

CSL Behring, LLC

Indicated in children and adults with hemophilia B (congenital Factor IX deficiency) for the (1) on-demand control and prevention of bleeding episodes

Moderate hemophilia B
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Orphan

Myozyme

Recombinant human acid alpha-glucosidase; alglucosidase alfa

Genzyme Corporation

Myozyme for use in patients with Pompe disease (GAA deficiency). Alglucosidase alfa has been shown to improve ventilator-free survival in patients wit

Glycogen storage disease due to acid maltase deficiencyInfantile Refsum disease
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Orphan

ATryn

recombinant human antithrombin

GTC Biotherapeutics, Inc.

Prevention of peri-operative and peri-partum thromboembolic events, in hereditary antithrombin deficient patients.

Congenital cataract-progressive muscular hypotonia-hearing loss-developmental delay syndromeAceruloplasminemia
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Orphan

Luveris

Recombinant human luteinizing hormone

EMD Serono, Inc.

Luveris (lutropin alfa for injection), concomitantly administered with Gonal-f (follitropin alfa for injection), is indicated for stimulation of folli

Rare disorder with female infertility due to a congenital hypogonadotropic hypogonadismKallmann syndrome
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Orphan⚠️ Black Box

Stivarga

regorafenib

Bayer HealthCare Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE STIVARGA is a kinase inhibitor indicated for the treatment of adult patients with: • Metastatic colorectal cancer (CRC) who ha

Adult hepatocellular carcinomaGastrointestinal stromal tumorHereditary nonpolyposis colon cancer
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Orphan

Ryoncil

remestemcel-L-rknd

Mesoblast, Inc.

1 INDICATIONS AND USAGE RYONCIL is indicated for the treatment of steroid refractory acute graft versus host disease (SR-aGvHD) in pediatric patients

Acute graft versus host disease
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Orphan

H.P. Acthar Gel

repository corticotropin or adrenocorticotropic hormone

Questcor Pharmaceuticals, Inc.

To treat infantile spasms

Cryptogenic late-onset epileptic spasmsView details →
Orphan

Augtyro

repotrectinib

Bristol Myers Squibb Company

1 INDICATIONS AND USAGE AUGTYRO is a kinase inhibitor indicated for the treatment of • adult patients with locally advanced or metastatic ROS1- positi

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

Respigam

Respiratory syncytial virus immune globulin (Human)

MedImmune & Massachussetts Public Health Biologics Labs.

For the prevention of serious lower respiratory tract infections caused by RSV in children less than 24 months of age with bronchopulmonary dysplasia

Susceptibility to respiratory infections associated with CD8alpha chain mutation
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Orphan

Zynyz

retifanlimab-dlwr

Incyte Corporation

1 INDICATIONS AND USAGE ZYNYZ is a programmed death receptor-1 (PD-1)–blocking antibody indicated: Squamous Cell Carcinoma of the Anal Canal (SCAC) in

Neuroendocrine tumor of anal canalCutaneous neuroendocrine carcinomaSquamous cell carcinoma of the anal canal
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Orphan

Encelto

revakinagene taroretcel-lwey

Neurotech Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE ENCELTO is indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel). ENCELTO is an allogen

NON RARE IN EUROPE: Macular telangiectasia type 2
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Orphan⚠️ Black Box

Revuforj

revumenib

Syndax Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE REVUFORJ is a menin inhibitor indicated for: the treatment of relapsed or refractory acute leukemia with a lysine methyltransf

Acute leukemia of ambiguous lineageView details →
Orphan

Rezzayo

rezafungin

Mundipharma GmbH

1 INDICATIONS AND USAGE REZZAYO is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative option

Transient predisposition to invasive pyogenic bacterial infectionView details →
Orphan

WinRho SD

Rho (D) immune globulin intravenous (human)

Rh Pharmaceuticals, Inc.

Treatment of adults and children with chronic and acute immune thrombocytopenic purpura.

Immune thrombocytopenia
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Orphan⚠️ Black Box

REBETOL

ribavirin

Schering Corporation

INDICATIONS AND USAGE Ribavirin for inhalation solution, USP is indicated for the treatment of hospitalized infants and young children with severe low

IgG4-related dacryoadenitis and sialadenitis
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Orphan

Epioxa HD and Epioxa

riboflavin 5'-phosphate

Glaukos Corporation

1 INDICATIONS AND USAGE EPIOXA HD and EPIOXA are indicated in epithelium-on corneal collagen cross-linking for the treatment of keratoconus in adults

Syndromic genetic keratoconus
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Orphan

Photrexa Viscous

riboflavin ophthalmic solution & ultraviolet A

Glaukos Corporation

Indicated for use in corneal collagen crosslinking in combination with the KXL� System for the treatment of progressive keratoconus ||| Treatment of

OBSOLETE: Keratoconus
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Orphan

Mycobutin

Rifabutin

Adria Laboratories, Inc.

INDICATIONS AND USAGE Rifabutin capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with a

OBSOLETE: Mycobacterium xenopi infectionPulmonary non-tuberculous mycobacterial infection
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Orphan

Rifadin I.V.

Rifampin

Hoechst Marion Roussel

INDICATIONS AND USAGE In the treatment of both tuberculosis and the meningococcal carrier state, the small number of resistant cells present within la

Pulmonary non-tuberculous mycobacterial infectionView details →
Orphan

Rifater

Rifampin, isoniazid, pyrazinamide

Hoechst Marion Roussel

Short-course treatment of tuberculosis.

Primary cutaneous tuberculosis
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Orphan

Priftin

Rifapentine

Hoechst Marion Roussel

1 INDICATIONS AND USAGE PRIFTIN is a rifamycin antimycobacterial drug indicated in patients 12 years of age and older for the treatment of active pulm

Primary pulmonary tuberculosisYersinia pseudotuberculosis infection
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