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

Camzyos

mavacamten

MyoKardia, Inc. (A Wholly-Owned Subsidiary of Bristol Myers Squibb)

1 INDICATIONS AND USAGE CAMZYOS ® is indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive

Non-familial hypertrophic cardiomyopathyRare hypertrophic cardiomyopathy
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Orphan

Xolremdi

mavorixafor

X4 Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE XOLREMDI is indicated in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and m

WHIM syndrome
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Orphan

VERMOX 500 mg chewable tablets

mebendazole

Janssen Pharmaceutical Research & Development, LLC

1 INDICATIONS AND USAGE VERMOX™ CHEWABLE is indicated for the treatment of patients one year of age and older with gastrointestinal infections caused

Patent ductus arteriosus-bicuspid aortic valve-hand anomalies syndromeAnkylostomiasisListeriosis
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Orphan

Increlex

Mecasermin

Eton Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE INCRELEX (mecasermin) injection is indicated for the treatment of growth failure in pediatric patients 2 years of age and olde

Growth hormone insensitivity syndromeShort stature due to primary acid-labile subunit deficiencyShort stature due to growth hormone qualitative anomaly
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Orphan

Iplex

mecasermin rinfabate

Insmed, Inc.

Treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have develop

Growth hormone insensitivity syndromeView details →
Orphan

Valchlor

meclorethamine

Helsinn Birex Pharmaceuticals Ltd.

1 INDICATIONS AND USAGE VALCHLOR is indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patient

Classic mycosis fungoidesHydroa vacciniforme-like lymphoma
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Orphan

Lariam

mefloquine HCL

Hoffmann-La Roche, Inc.

Treatment of acute malaria due to Plasmodium falciparum and Plasmodium vivax ||| Prophylaxis of Plasmodium falciparum malaria which is resistant to ot

AceruloplasminemiaView details →
Orphan

Megace

Megestrol acetate

Bristol-Myers Squibb Pharmaceutical Research Institute

INDICATIONS AND USAGE Megestrol acetate oral suspension, USP is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weig

Aicardi-Goutières syndromeOBSOLETE: Syndromic ichthyosis associated with ocular featuresAnti-neutrophil cytoplasmic antibody-associated vasculitisNLRP3-associated autoinflammatory disease
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Orphan⚠️ Black Box

Mobic

meloxicam

Avondale Pharmaceuticals

1 INDICATIONS AND USAGE Meloxicam tablet USP is a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) ( 1.1 ) Rheumatoid Arthritis

Juvenile idiopathic arthritis
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Orphan⚠️ Black Box

Alkeran For Injection

Melphalan

Glaxo Wellcome Inc.

INDICATIONS AND USAGE Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral

Steatocystoma multiplex-natal teeth syndrome
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Orphan

Pepaxto

melphalan flufenamide

Oncopeptides AB

Treatment, in combination with dexamethasone, of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lin

Familial platelet disorder with associated myeloid malignancyView details →
Orphan

NUCALA

mepolizumab

GlaxoSmithKline LLC

1 INDICATIONS AND USAGE NUCALA is an interleukin-5 (IL-5) antagonist monoclonal antibody (IgG1 kappa) indicated for: • Add-on maintenance treatment of

Eosinophilic granulomatosis with polyangiitisHypereosinophilic syndrome
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Orphan

Purixan

mercaptopurine oral solution

Nova Laboratories Limited

1 INDICATIONS AND USAGE PURIXAN is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as

Acute myeloblastic leukemia with maturationView details →

MESALAMINE

MESALAMINE

KLM Laboratories Private Limited

View details →
Orphan

Lialda

mesalamine; 5-aminosalicylic acid

Takeda Development Center Americas, Inc.

1 INDICATIONS AND USAGE LIALDA ® is indicated for the: induction and maintenance of remission in adult patients with mildly to moderately active ulcer

NON RARE IN EUROPE: Peyronie syndrome
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Orphan

Mesnex

Mesna

Degussa Corporation

1 INDICATIONS AND USAGE MESNEX is indicated as a prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. Limitation o

View details →
Orphan⚠️ Black Box

Xatmep

methotrexate oral solution

Silvergate Pharmaeuticals, Inc.

1 INDICATIONS AND USAGE XATMEP is a folate analog metabolic inhibitor indicated for the: Treatment of pediatric patients with acute lymphoblastic leuk

Rheumatoid factor-positive polyarticular juvenile idiopathic arthritisAcute lymphoblastic leukemia
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Orphan⚠️ Black Box

Methotrexate

Methotrexate sodium

Lederle Laboratories

1 INDICATIONS AND USAGE Methotrexate tablets are a diydrofolate reductase inhibitor indicated for the: • Treatment of adults and pediatric patients wi

Juvenile idiopathic arthritisAcute lymphoblastic leukemiaClassic mycosis fungoides
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METHYLENE BLUE

METHYLENE BLUE

Zydus Lifesciences Limited

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Orphan⚠️ Black Box

ProvayBlue

methylene blue0.5%

Provepharm SAS

1 INDICATIONS AND USAGE PROVAYBLUE is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. PROVAYBLUE (methyle

Acquired methemoglobinemia
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⚠️ Black Box

METHYLPHENIDATE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE

Granules Pharmaceuticals Inc.

1 INDICATIONS AND USAGE Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Dis

Rare genetic hyperkinetic movement disorder
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Orphan

Methylprednisolone

METHYLPREDNISOLONE

Bryant Ranch Prepack

INDICATIONS AND USAGE Methylprednisolone tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical

View details →
Orphan

Methylprednisolone Acetate

METHYLPREDNISOLONE ACETATE

A-S Medication Solutions

INDICATIONS AND USAGE A. For Intramuscular Administration When oral therapy is not feasible and the strength, dosage form, and route of administration

View details →
Orphan⚠️ Black Box

Dyural 80-Lm

METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, ISOPROPYL ALCOHOL

Advanced Rx Pharmacy of Tennessee, LLC

1 INDICATIONS AND USAGE Bupivacaine Hydrochloride Injection is indicated in adults for the production of local or regional anesthesia or analgesia for

Diamond-Blackfan anemiaImmune thrombocytopeniaExfoliative ichthyosisClassic mycosis fungoidesEosinophilic gastroenteritisBronchiolitis obliteransMixed-type autoimmune hemolytic anemiaPyomyositisRare malignant epithelial tumor of liver and intrahepatic biliary tractCongenital dyserythropoietic anemia type ICongenital disorder of glycosylation with neurological involvementDermatitis herpetiformisOccipital pachygyria and polymicrogyriaIgA pemphigusStevens-Johnson syndromeAcute adrenal insufficiencyCongenital adrenal hyperplasiaHIV-associated cancer
View details →
Orphan⚠️ Black Box

Dyural 40 Kit

METHYLPREDNISOLONE ACETATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE, SODIUM CHLORIDE, ISOPROPYL ALCOHOL

Advanced Rx Pharmacy of Tennessee, LLC

1 INDICATIONS AND USAGE Bupivacaine Hydrochloride Injection is indicated in adults for the production of local or regional anesthesia or analgesia for

View details →
Orphan

Methylprednisolone Sodium Succinate

METHYLPREDNISOLONE SODIUM SUCCINATE

Hikma Pharmaceuticals USA Inc.

INDICATIONS AND USAGE When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the pr

View details →
Orphan⚠️ Black Box

MYALEPT

metreleptin

Chiesi Farmaceutici S.p.A.

1 INDICATIONS AND USAGE MYALEPT is a leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficie

AKT2-related familial partial lipodystrophyCongenital generalized lipodystrophyAcquired generalized lipodystrophy
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METRONIDAZOLE

METRONIDAZOLE

B. Braun Medical Inc.

View details →
Orphan

Metrogel

Metronidazole (topical)

Galderma Laboratories, Inc.

1 INDICATIONS AND USAGE METROGEL, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. METROGEL, 1% is a nitroimidazole indic

Mixed neuroendocrine and non-neuroendocrine neoplasm of pancreas
View details →
Orphan⚠️ Black Box

NAYZILAM

midazolam

UCB, Inc.

1 INDICATIONS AND USAGE NAYZILAM is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizur

Cytomegalovirus disease in patients with impaired cell mediated immunity deemed at riskView details →
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