Therapy Area/ Disease

According to FDA (Food and Drug Administration), the following are listed the Therapeutic Areas and disease categorized in them.

Therapeutic Areas

Diseases categorized under Therapeutic Areas

Addiction

  • Maintenance of abstinence from alcohol in patients with alcohol dependency

  • Neonatal abstinence syndrome (NAS)

  • Smoking cessation

Allergy

  • Type I/II hereditary angioedema

Analgesia/Anesthesiology/Anti-inflammatory

  • Anesthesia

  • Anxiolysis

  • Fever reduction

  • Pain

    • Chronic

    • Malignancy-related breakthrough pain

    • Mild

    • Moderate

    • Post-operative

    • Severe

  • Reversal of neuromuscular blockage

  • Sedation

    • Initially intubated & mechanically ventilated pediatric subjects in an intensive care setting

  • Skeletal muscle relaxation to facilitate rapid sequence and routine endotracheal intubation

Cardiovascular Disease

  • Acute coronary disease

  • Congenital heart disease

  • Congestive heart failure

    • Heart failure due to systemic left ventricular systolic dysfunction

  • Dilated Cardiomyopathy (DCM) and symptomatic chronic heart failure

  • Hypertension

    • General

    • Post-operative hypertension

  • Pulmonary hypertension

    • Primary/secondary

    • Post-surgical

  • Raynaud's Phenomenon

  • Tachyarrhythmia

Dermatology

  • Alopecia areata

  • Aphthous ulcer

  • Candidiasis (cutaneous, oropharyngeal)

  • Dermatosis (steroid-responsive dermatosis)

  • Dermatitis (atopic dermatitis)

  • Ichthyosis vulgaris

  • Idiopathic urticaria (chronic)

  • Mild to moderate plaque psoriasis

  • Molluscum contagiosum

  • Onychomycosis of the toenail

  • Oral mucositis

  • Pediculosis humanis capitis (head lice and their ova)

  • Severe recalcitrant nodular acne

  • Skin and skin structure infections

  • Tinea

    • Capitis

    • Cruris

    • Pedis

Endocrinology/Metabolism/Bone

  • Acromegalic gigantism

  • Bone mineral density (BMD)

    • BMD in anorexia nervosa patients

    • BMD in osteogenesis imperfecta patients

    • BMD in postmenarcheal adolescents with secondary amenorrhea

  • Central Precocious Puberty (CPP)

  • Delayed puberty in boys with primary and secondary hypogonadism

  • Diabetes Mellitus

    • Type 1

    • Type 2

  • Failure to thrive in pediatric AIDS patients

  • Growth-hormone-secreting lesions of the pituitary gland

  • Gynecomastia

  • Homozygous familial hypercholesterolemia (HoFH)

  • Hypercholesterolemia (heterozygous familial hypercholesterolemia)

  • Hyperparathyroidism (renal failure secondary to hyperparathyroidism)

  • Hypocalcemia management in patients on hemodialysis

  • McCune-Albright Syndrome

  • Obesity

    • General

    • Hypothalamic

  • Osteogenesis Imperfecta (OI)

  • Tetrahydrobiopterin- (BH4-) responsive phenylketonuria (PKU)

  • Testotoxicosis

Gastroenterology

  • Antiemesis

    • Treatment and prevention of nausea and vomiting associated with emetogenic chemotherapy

    • Prevention of post-operative nausea and vomiting

  • Clostridium difficile-associated diarrhea (CDAD)

  • Constipation (general )

  • Crohn's Disease

  • Diarrhea (acute)

  • Erosive Esophagitis

  • Gastroesophageal Reflux Disease (GERD)

  • Irritable Bowel Syndrome (IBS)

    • IBS-D

  • Nephropathic cystinosis

  • Short Bowel Syndrome (SBS)

  • Ulcerative Colitis (UC)

  • Ulcers

Hematology/Coagulation

  • Deep vein thrombosis (DVT)

  • Iron deficiency in patients undergoing chronic hemodialysis

  • Iron overload due to blood transfusions-dependent anemia (chronic)

  • Sickle cell disease

  • Thrombocythemia

  • Thrombocytopenia

  • Thromboembolism

Immunomodulators

  • Immune suppression

  • Prevention of organ rejection following renal transplantation

Infectious Disease (viral)

  • Cytomegalovirus (CMV)

  • Hepatitis B virus (HBV)

    • Chronic

  • Hepatitis C virus (HCV)

    • Chronic

  • Herpes simplex virus (HSV)

  • Human Immunodeficiency Virus (HIV) infection

    • prophylaxis of HIV infection in exposed neonates

    • perinatal transmission of HIV infection

  • Influenza A/B

  • Perinatal transmission of HIV infection

  • Symptoms associated with common cold and influenza

  • Varicella zoster virus (VZV)

Infectious Disease (non viral)

  • Acute pyelonephritis

  • Aspergillosis (invasive)

  • Candidiasis

  • Cerebrospinal fluid (CSF) shunt infection

  • Community-acquired pneumonia (CAP)

  • Complicated intra-abdominal infections (cIAI)

  • Complicated UTI

    • Acute pyelonephritis

  • Fungal infection (invasive)

    • Associated fever and neutropenia

  • Helicobacter pylori infection (H. pylori)

  • Malaria

  • Meningitis (bacterial)

  • Mold infections (rare mold)

  • Otitis media (OM)(recurrent)/OM treatment failures

  • Pneumonia (bacteremic)

  • Resistant infection or infections unresponsive to the first choice antibiotic

  • Skin and skin structure infections

  • Tuberculosis

Medical Imaging

  • Cardiac imaging

  • Lesions in the central nervous system, body, extracranial/extraspinal tissues

  • Myocardial perfusion imaging

Neurology

  • Duchene muscular dystrophy

  • Insomnia in patients with ADHD

  • Intractable seizures associated with Dravet syndrome

  • Migraine

  • Multiple sclerosis (MS)

    • Relapsing forms of MS

  • Narcolepsy

    • Cataplexy in narcolepsy

  • Neuroblastoma

    • High-risk refractory or relapsed neuroblastoma” under Neuroblastoma

  • Seizures

    • Generalized

  • Lennox-Gastaut Sundrome (LGS)

  • Partial

    • With or without secondarily generalized seizures

  • Spasticity management

  • Obstructive sleep apnea (OSA) (excessive sleepiness in OSA)

  • Tourette’s syndrome

    • ADHD in patients with Tourette's disorder

Oncology

  • Allogeneic bone marrow transplants

  • Chemotherapy toxicity protection

  • Chronic Graft Versus Host Disease (GVHD)

  • CNS malignancies and solid tumors

  • Giant cell tumor of bone and osteosarcoma

  • Hematologic tumors

    • CNS lymphomas

      • Low grade gliomas

      • High grade gliomas

      • Recurrent, progressive, or refractory brain tumors

    • Leukemia

      • Acute lymphoblastic leukemia

      • Acute myelogenous leukemia

      • CNS leukemia

      • Mixed linear acute leukemia

      • Philadelphia positive (Ph+) chronic myelogenous leukemia

    • Hodgkin's lymphoma

    • Non-Hodgkin's lymphoma

      • Anaplastic large cell lymphoma

      • Mature B-cell NHL

    • Hematopoietic stem cell mobilization in patients with pediatric malignancies eligible for autologous stem cell transplantation

    • Melanoma

    • Myelodysplastic syndromes

    • Neuroblastoma

    • Osteosarcoma

    • Pediatric malignancies

    • Refractory/relapse malignancies

      • Advanced relapsed/refractory malignant solid tumors with activation of the RAS/RAF/MEK signaling pathway.

      • Relapsed or refractory solid tumors containing BRAF V600 activating mutations and in the treatment of adolescent patients with unresectable or metastatic melanoma containing BRAF V600 activating mutations.

      • Relapsed or refractory tumors with ErbB1 or Erb B2 pathway dysregulation.

      • Rhabdomyosarcoma and non-rhabdomyosarcomatous soft tissue sarcoma.

    Ophthalmology

    • Conjunctivitis

      • Allergic

      • Bacterial

      • Neonatal

    • Intraocular pressure

    • Post-operative inflammation following cataract surgery

    • Retinopathy of prematurity (ROP)

    • Uveitis

    Psychiatry

    • Adolescent schizophrenia

    • Attention deficit hyperactivity disorder (ADHD)

    • Autism and Autism Spectrum Disorder

      • Core social impairment symptoms

    • Bipolar disorder (mania associated with bipolar disorder)

    • Depression/Major Depressive Disorder (MDD)

    • General Anxiety Disorder (GAD)

    • Obsessive compulsive disorder (OCD)

    • Panic disorder

    Pulmonary

    • Allergic Rhinitis

    • Asthma

    • Bronchopulmonary dysplasia

    • Bronchospasm (treatment and prevention)

      • Prevention of bronchospasm in patients with obstructive airway disease

    • Cystic Fibrosis

    Renal Disease

    • Anemia due to chronic kidney disease (CKD)

    • End stage renal disease

    • Hyperphosphatemia due to chronic kidney disease

    • Hyponatremia

    Rheumatology

    • Familial Mediterranean Fever (FMF)

    • Juvenile Idiopathic Arthritis (JIA)/Juvenile Rheumatoid Arthritis (JRA)

      • Polyarticular Juvenile Idiopathic Arthritis (PJIA)

    • Management of fibromyalgia

    Urologic

    • Detrusor Hyperreflexia

    • Detrusor overactivity in neurological condition