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.

KETALAR

KETAMINE HYDROCHLORIDE

Par Health USA, LLC

1 INDICATIONS AND USAGE KETALAR (ketamine hydrochloride) injection is indicated: as the sole anesthetic agent for diagnostic and surgical procedures t

Lethal Larsen-like syndromeView details →
Orphan

L-Glutamine

L-GLUTAMINE

ANI Pharmaceuticals, Inc.

INDICATIONS For the temporary relief of mild abdominal pain or discomfort, diarrhea, minor joint pain, general weakness, muscle fatigue, sadness, or a

Gamma-glutamyl transpeptidase deficiencyView details →

KRISTALOSE

LACTULOSE

Cumberland Pharmaceuticals Inc.

View details →
Orphan⚠️ Black Box

Lamictal

Lamotrigine

Glaxo Wellcome Research and Development

1 INDICATIONS AND USAGE LAMICTAL XR is indicated for: • adjunctive therapy for primary generalized tonic-clonic seizures (PGTC) and partial-onset seiz

Lennox-Gastaut syndromeEating reflex epilepsyEpilepsy with generalized tonic-clonic seizures alone
View details →
Orphan

TAKHZYRO

LANADELUMAB-FLYO

Takeda Pharmaceuticals America, Inc.

1 INDICATIONS AND USAGE TAKHZYRO ® is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged

Hereditary angioedema
View details →
Orphan

Somatuline Depot

Lanreotide

IPSEN, Inc.

1 INDICATIONS AND USAGE SOMATULINE DEPOT is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inade

Trichohepatoenteric syndromeCarcinoid syndromeAcromegalyGastroenteropancreatic neuroendocrine neoplasm
View details →
Orphan⚠️ Black Box

ALDURAZYME

LARONIDASE

Genzyme Corporation

1 INDICATIONS AND USAGE ALDURAZYME ® is indicated for the treatment of: adult and pediatric patients with Hurler and Hurler-Scheie forms of Mucopolysa

Hurler syndromeHurler-Scheie syndrome
View details →
Orphan

VITRAKVI

larotrectinib

Bayer HealthCare Pharmaceuticals Inc.

1 INDICATIONS AND USAGE VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor t

Embryonal tumor with multilayered rosettesIsolated persistent urogenital sinus
View details →
Orphan⚠️ Black Box

Harvoni

ledipasvir/sofosbuvir

Gilead Sciences, Inc.

1 INDICATIONS AND USAGE HARVONI is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C viru

Recurrent hepatitis C virus induced liver disease in liver transplant recipients
View details →
Orphan⚠️ Black Box

Lenalidomide

LENALIDOMIDE

Teva Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with: Multiple myeloma (MM), in combinati

Myelodysplastic syndromeMultiple myeloma
View details →
Orphan

Joenja

leniolisib

Pharming Technologies B.V.

1 INDICATIONS AND USAGE JOENJA is indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediat

Activated PI3K-delta syndromeActivated PI3K-delta syndrome 1
View details →
Orphan

LENVIMA

lenvatinib

Eisai Inc.

1 INDICATIONS AND USAGE LENVIMA is a kinase inhibitor that is indicated: Differentiated Thyroid Cancer (DTC) For the treatment of adult patients with

Adult hepatocellular carcinomaDifferentiated thyroid carcinomaRenal cell carcinomaOBSOLETE: Renal cell carcinoma associated with neuroblastoma
View details →
Orphan

Refluden

Lepirudin

Hoechst Marion Roussel

For anticoagulation in patients with heparin-induced thrombocytopenia and associated thromboembolic disease in order to prevent further thromboembolic

Classic heparin-induced thrombocytopenia
View details →
Orphan

PREVYMIS

letermovir

Merck Sharp & Dohme LLC

1 INDICATIONS AND USAGE PREVYMIS is a CMV DNA terminase complex inhibitor indicated for: Prophylaxis of cytomegalovirus (CMV) infection and disease in

Complications after hematopoietic stem cell transplantation
View details →
Orphan

Leucovorin calcium

Leucovorin

Immunex Corporation

INDICATIONS AND USAGE Leucovorin calcium rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin calcium is also indicate

Syndrome with difference of sex development of gynecological interestOsteosarcomaCongenital intrinsic factor deficiencyMethotrexate toxicityFamilial colorectal cancer Type X
View details →
Orphan

Lupron Depot-Ped

Leuprolide acetate

AbbVie Endocrine Inc.

1 INDICATIONS AND USAGE LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP). LUPRON DEPOT-PED

Rare central precocious puberty
View details →
Orphan

AQNEURSA

LEVACETYLLEUCINE

IntraBio Inc

1 INDICATIONS AND USAGE AQNEURSA™ is indicated for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and ped

Niemann-Pick disease type C
View details →

LEVETIRACETAM SOLUTION

LEVETIRACETAM

Chartwell RX, LLC

View details →
Orphan

Carnitor

Levocarnitine

Leadiant Biosciences, Inc.

INDICATIONS AND USAGE CARNITOR ® (levocarnitine) is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the cl

Systemic primary carnitine deficiency
View details →

INBRIJA

LEVODOPA

Merz Pharmaceuticals, LLC

View details →
Orphan⚠️ Black Box

Recorlev

levoketoconazole

Strongbridge Dublin Limited

1 INDICATIONS AND USAGE RECORLEV is indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom sur

Endogenous Cushing syndrome
View details →
Orphan

Fusilev

levoleucovorin

Acrotech Biopharma LLC

1 INDICATIONS AND USAGE Levoleucovorin Injection is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with os

OsteosarcomaMethotrexate toxicityHereditary nonpolyposis colon cancer
View details →
Orphan

Orlaam

Levomethadyl acetate hydrochloride

Biodevelopment Corporation

For the management of opiate dependence.

Rare non surgically correctable form of primary aldosteronismACTH-dependent Cushing syndrome
View details →
Orphan

Physician Ez Use Joint Tunnel And Trigger Kit Ii

LIDOCAINE HYDROCHLORIDE, TRIAMCINOLONE ACETONIDE, POVIDONE-IODINE

Asclemed USA, Inc.

INDICATIONS AND USAGE Intramuscular Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectabl

View details →
Orphan

Lidoderm Patch

Lidocaine patch 5%

Teikoku Pharma USA, Inc.

INDICATION AND USAGE LIDODERM is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin .

Hereditary sensory and autonomic neuropathy type 5NON RARE IN EUROPE: Post-herpetic neuralgia
View details →
Orphan

Lidolog Kit

LIDOCAINE, KENALOG, POVIDONE IODINE

Asclemed USA, Inc.

INDICATIONS AND USAGE Lidocaine hydrochloride injection is indicated for production of local or regional anesthesia by infiltration techniques such as

View details →
Orphan⚠️ Black Box

Amtagvi

lifileucel

Iovance Biotherapeutics, Inc.

1 INDICATIONS AND USAGE AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or

Primary melanoma of the central nervous systemConjunctival malignant melanoma
View details →
Orphan

Lynavoy

linerixibat

GlaxoSmithKline

treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients

Primary biliary cholangitisView details →
Orphan⚠️ Black Box

Lynozyfic

linvoseltamab-gcpt

Regeneron Pharmaceuticals, Inc.

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

Multiple myeloma
View details →
Orphan

Triostat

Liothyronine sodium injection

SmithKline Beecham Pharmaceuticals

Treatment of myxedema coma/precoma.

Hypo- and hypermelanotic cutaneous macules-retarded growth-intellectual disability syndromeMyeloid sarcoma
View details →
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