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⚠️ Black Box

Valproic Acid

VALPROIC ACID

Direct_Rx

These highlights do not include all the information needed to use VALPROIC ACID CAPSULES safely and effectively. See full prescribing information for

Juvenile absence epilepsy
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Orphan

Valstar

Valrubicin

Anthra Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CI

Small cell carcinoma of the bladder
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VALSARTAN

VALSARTAN

Laurus Labs Limited

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Orphan

AGAMREE

VAMOROLONE

Catalyst Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE AGAMREE is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. AGAMREE is a

Duchenne muscular dystrophy
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Orphan⚠️ Black Box

CAPRELSA(r)

vandetanib

Genzyme Corporation

1 INDICATIONS AND USAGE CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable l

Deafness with labyrinthine aplasia, microtia, and microdontiaMedullary thyroid carcinoma
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ALYFTREK

VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR

Vertex Pharmaceuticals Incorporated

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⚠️ Black Box

ALYFTREK

VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR

Vertex Pharmaceuticals Incorporated

1 INDICATIONS AND USAGE ALYFTREK is indicated for the treatment of cystic fibrosis (CF) in patients 6 years of age and older who have at least one F50

Cystic fibrosis
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⚠️ Black Box

ALYFTREK

VANZACAFTOR, TEZACAFTOR, AND DEUTIVACAFTOR

Vertex Pharmaceuticals Incorporated

1 INDICATIONS AND USAGE ALYFTREK is indicated for the treatment of cystic fibrosis (CF) in patients 6 years of age and older who have at least one F50

Cystic fibrosis
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Orphan

VARIZIG

Varicella Zoster Immune Globulin (Human)

Cangene bioPharma, Inc.

Post exposure prophylaxis of varicella in high risk individuals to reduce the severity of varicella

Severe mendelian susceptibility to mycobacterial diseases due to complete IFNG deficiencyView details →
Orphan⚠️ Black Box

VPRIV

VELAGLUCERASE ALFA

Takeda Pharmaceuticals America, Inc.

1 INDICATIONS AND USAGE VPRIV is indicated for long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease. VPRIV is a hydroly

Gaucher disease
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Orphan⚠️ Black Box

Lamzede

VELMANASE ALFA-TYCV

Chiesi USA, Inc.

1 INDICA TIONS AND USAGE LAMZEDE is indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediat

Alpha-mannosidosis
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Orphan

Zelboraf

VEMURAFENIB

Genentech, Inc.

1 INDICATIONS AND USAGE ZELBORAF ® is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V6

Erdheim-Chester diseaseConjunctival malignant melanoma
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Orphan

VENCLEXTA

venetoclax

AbbVie, Inc

1 INDICATIONS AND USAGE VENCLEXTA is a BCL-2 inhibitor indicated: For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small

Acute myeloid leukemiaB-cell chronic lymphocytic leukemia
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Orphan⚠️ Black Box

MEPSEVII

VESTRONIDASE ALFA

Ultragenyx Pharmaceutical Inc.

1 INDICATIONS AND USAGE MEPSEVII is indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome).

Mucopolysaccharidosis type 7
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⚠️ Black Box

VIGABATRIN

VIGABATRIN

Hikma Pharmaceuticals USA Inc

1 INDICATIONS AND USAGE Vigabatrin tablets are indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2

Cryptogenic late-onset epileptic spasmsRefractory celiac disease
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Orphan

Viltepso

VILTOLARSEN

NS Pharma, Inc.

1 INDICATIONS AND USAGE VILTEPSO is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the

Duchenne muscular dystrophy
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Orphan

Marqibo

vinCRIStine sulfate LIPOSOME injection

Acrotech Biopharma LLC

Treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disea

Acute lymphoblastic leukemiaPrecursor T-cell acute lymphoblastic leukemia
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Orphan

Vonvendi

von Willebrand factor (recombinant)

Takeda Pharmaceuticals U.S.A., Inc.

For use in adults (age 18 and older) diagnosed with von Willebrand disease (VWD) for routine prophylaxis to reduce the frequency of bleeding episodes

Pseudo-von Willebrand diseaseVon Willebrand disease type 3
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Orphan

Wilate

von Willebrand Factor/Coagulation Factor VIII Complex (Human)

Octapharma USA, Inc.

Treatment of spontaneous or trauma-induced bleeding episodes in patients with severe von Willebrand disease (VWD) as well as patients with mild or mod

Hematological disease associated with an acquired peripheral neuropathyVon Willebrand disease type 3Von Willebrand disease
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Orphan

Voranigo

vorasidenib

Servier Pharmaceuticals LLC

1 INDICATIONS AND USAGE VORANIGO is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligode

Angiocentric gliomaPrader-Willi syndrome due to imprinting mutationAcute myeloid leukemia with NPM1 somatic mutations
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Orphan

LUXTURNA

voretigene neparvovec-rzyl

Spark Therapeutics, Inc.

1 INDICATIONS AND USAGE LUXTURNA (voretigene neparvovec-rzyl) is an adeno-associated virus vector-based gene therapy indicated for the treatment of pa

OBSOLETE: Inherited retinal disorder
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Orphan

Zolinza

vorinostat

Merck & Co., Inc.

1 INDICATIONS AND USAGE ZOLINZA ® is indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progr

T-cell non-Hodgkin lymphomaPrimary cutaneous T-cell lymphoma
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Orphan

Voxzogo 0.4Mg

VOSORITIDE

BioMarin Pharmaceutical Inc.

1 INDICATIONS AND USAGE VOXZOGO is indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. This indication

Achondroplasia
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Orphan

OXBRYTA

VOXELOTOR

Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc.

1 INDICATIONS AND USAGE OXBRYTA is indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 4 years of age and older.

Sickle cell disease
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Orphan

AMVUTTRA

VUTRISIRAN

Alnylam Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE AMVUTTRA is a transthyretin-directed small interfering RNA indicated for the treatment of: the polyneuropathy of hereditary tr

Hereditary transthyretin-mediated amyloidosisHereditary ATTR amyloidosisWild type ATTR amyloidosis
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Orphan

Vyjuvek

VYJUVEK

Krystal Biotech, Inc.

1 INDICATIONS AND USAGE VYJUVEK is indicated for the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa (DEB) w

Dystrophic epidermolysis bullosa
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Orphan

Sterile Diluent For Treprostinil

WATER

Dr.Reddy's Laboratories Inc.,

1 INDICATIONS AND USAGE Treprostinil injection is a prostacyclin vasodilator indicated for: Treatment of pulmonary arterial hypertension (PAH; WHO Gro

Pulmonary arterial hypertension associated with portal hypertension
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Orphan

Hivid

Zalcitabine

Hoffmann-La Roche, Inc.

Combination therapy with zidovudine is indicated for the treatment of adult patients with advanced HIV infection (CD4 count < 300) who have demonstrat

AA amyloidosisCongenital Epstein-Barr virus infection
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Orphan⚠️ Black Box

Ziihera

zanidatamab-hrii

Jazz Pharmaceuticals Ireland Limited

1 INDICATIONS AND USAGE ZIIHERA is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) bi

Rare urinary tract tumor
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Orphan

BRUKINSA

zanubrutinib

BeOne Medicines USA, Inc.

1 INDICATIONS AND USAGE BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Mantle cell lymphoma (MCL) who have receive

T-cell prolymphocytic leukemiaWaldenström MacroglobulinemiaFollicular lymphomaB-cell chronic lymphocytic leukemiaMantle cell lymphomaMarginal zone lymphoma
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