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.
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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.

GLYCEROL PHENYLBUTYRATE

GLYCEROL PHENYLBUTYRATE

Novadoz Pharmaceuticals LLC

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GLYCEROL PHENYLBUTYRATE

GLYCEROL PHENYLBUTYRATE

Aurobindo Pharma Limited

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GLYCEROL PHENYLBUTYRATE

GLYCEROL PHENYLBUTYRATE

Novadoz Pharmaceuticals LLC

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GLYCEROL PHENYLBUTYRATE

GLYCEROL PHENYLBUTYRATE

Aurobindo Pharma Limited

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GLYCEROL PHENYLBUTYRATE

GLYCEROL PHENYLBUTYRATE

Teva Pharmaceuticals, Inc.

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GLYCEROL PHENYLBUTYRATE

GLYCEROL PHENYLBUTYRATE

Novadoz Pharmaceuticals LLC

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GLYCEROL PHENYLBUTYRATE

GLYCEROL PHENYLBUTYRATE

Teva Pharmaceuticals, Inc.

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GLYCEROL PHENYLBUTYRATE

GLYCEROL PHENYLBUTYRATE

Novadoz Pharmaceuticals LLC

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GLYCEROL PHENYLBUTYRATE

GLYCEROL PHENYLBUTYRATE

Novadoz Pharmaceuticals LLC

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GLYCEROL PHENYLBUTYRATE

GLYCEROL PHENYLBUTYRATE

Teva Pharmaceuticals, Inc.

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GLYCEROL PHENYLBUTYRATE

GLYCEROL PHENYLBUTYRATE

Aurobindo Pharma Limited

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Orphan

Glycerol Phenylbutyrate

GLYCEROL PHENYLBUTYRATE ORAL

Par Health USA, LLC

1 INDICATIONS AND USAGE Glycerol phenylbutyrate oral liquid is indicated for use as a nitrogen-binding agent for chronic management of patients with u

Urea Cycle Disorder
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Orphan

Cuvposa

glycopyrrolate

Shionogi, Inc.

1 INDICATIONS AND USAGE CUVPOSA is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated wi

Neurometabolic disorder due to serine deficiencyView details →
Orphan⚠️ Black Box

SIMPONI ARIA�

golimumab

Janssen Research & Development, LLC

1 INDICATIONS AND USAGE SIMPONI ARIA is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with moderately to severe

Polyarticular juvenile idiopathic arthritisJuvenile idiopathic arthritisPsoriasis-related juvenile idiopathic arthritisNON RARE IN EUROPE: Ankylosing spondylitis
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Orphan

Vyondys 53

GOLODIRSEN

Sarepta Therapeutics, Inc.

1 INDICATIONS AND USAGE VYONDYS 53 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of th

Duchenne muscular dystrophy
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Orphan

Lutrepulse

Gonadorelin acetate

Ferring Laboratories, Inc.

Immune dysregulation disease with immunodeficiency associated with EBV susceptibility
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Orphan

Halfan

Halofantrine

SmithKline Beecham Pharmaceuticals

Treatment of adults who can tolerate oral medication and who have mild to moderate malaria caused by Plasmodium falciparum or Plasmodium vivax.

OBSOLETE: Bacterial susceptibility due to TLR signaling pathway deficiencyView details →

HALOPERIDOL

HALOPERIDOL

AiPing Pharmaceutical, Inc

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HALOPERIDOL DECANOATE

HALOPERIDOL DECANOATE

NorthStar RxLLC

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Orphan

Panhematin

Hemin

Abbott Laboratories

1 INDICATIONS AND USAGE PANHEMATIN is a hemin for injection indicated for the amelioration of recurrent attacks of acute intermittent porphyria tempor

Digital extensor muscle aplasia-polyneuropathy
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Orphan

HepaGam B

hepatitis B immune globulin (human)

Cangene Corporation

INDICATIONS AND USAGE Nabi-HB, Hepatitis B Immune Globulin (Human), is indicated for treatment of acute exposure to blood containing HBsAg, perinatal

Hepatitis B reinfection following liver transplantationFetal minoxidil syndromeHepatitis delta
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Orphan

Supprelin LA

Histrelin

Endo Pharmaceuticals Solutions, Inc.

1 INDICATIONS AND USAGE SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puber

Rare central precocious puberty
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Orphan

Supprelin Injection

Histrelin acetate

Roberts Pharmaceutical Corp.

1 INDICATIONS AND USAGE SUPPRELIN LA (histrelin acetate) subcutaneous implant is indicated for the treatment of children with central precocious puber

Rare central precocious puberty
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Orphan

RiaSTAP

human fibrinogen concentrate, pasteurized

CSL Behring, LLC

Treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia)

Congenital fibrinogen deficiencyFamilial afibrinogenemiaFamilial hypofibrinogenemia
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Orphan

Hydrocortisone

HYDROCORTISONE

Preferred Pharmaceuticals Inc.

INDICATIONS AND USAGE Hydrocortisone Tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical ins

Addison disease
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Orphan

Cyanokit

Hydroxocobalamin

SERB, S.A.

1 INDICATIONS AND USAGE CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning. CYANOKIT is indicated for the treatment of kn

Cyanide poisoning
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Orphan⚠️ Black Box

Siklos

hydroxycarbamide (hydroxyurea)

Theravia Pharma

1 INDICATIONS AND USAGE SIKLOS ® is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and ped

Hereditary persistence of fetal hemoglobin-sickle cell disease syndromeHyperimmunoglobulinemia D with periodic fever
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Orphan

Makena

hydroxyprogesterone caproate

AMAG Pharma USA, Inc.

INDICATIONS AND USAGE Hydroxyprogesterone Caproate Injection, USP is indicated in non-pregnant women: for the treatment of advanced adenocarcinoma of

Pancreatic arteriovenous malformationView details →
Orphan⚠️ Black Box

DROXIA

HYDROXYUREA

Waylis Therapeutics LLC

1 INDICATIONS AND USAGE DROXIA is indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in patients with s

OBSOLETE: Sickle cell disease associated with another hemoglobin anomalySickle cell disease
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Orphan

Trogarzo

ibalizumab

Theratechnologies Inc.

1 INDICATIONS AND USAGE TROGARZO, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (

Acute disseminated encephalomyelitis without anti-MOG antibodiesMendelian susceptibility to mycobacterial diseases due to complete RORgamma receptor deficiency
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