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New FDA Approved Drugs in 2019

Nov 2, 2019

Pharmacology expert, Dr. Gobind Rai Garg has come up with a comprehensive list of new drugs approved in 2019. The table includes the name of the drug, mechanism, route, and indication. This list will prove helpful to you for the upcoming competitive exams.

FDA-APPROVED DRUGS IN 2019

Drug Mechanism Route Indication
Afamelanotide Melanocortin 1 receptor agonist Subcutaneous Phototoxicity in patients with erythropoieticprotoporphyria
Alpelisib PI3 kinase inhibitor Oral Breast cancer
Amifampridine K channel blocker Oral Lambert Eaton Myasthenic syndrome
Andexanet alpha Bind to Factor Xa inhibitors Intravenous To reverse overdose of rivaroxaban and apixaban
Apalutamide Darolutamide Androgen receptor antagonist Oral Prostate carcinoma
Apremilast PDE-4 inhibitor Oral Oral ulcers associated with Behcet disease
Atezolizumab MAb against PDL-1 IV Extensive stage-Small Cell Lung Cancer
Avatrombopag Lusutrombopag Thrombopoietin receptor agonist Oral Thrombocytopenia in patients with chronic liver disease
Avelumab + Axitinib Avelumab: Anti-PDL-1 Axitinib: anti-VEGF kinase Avelumab: IV Axitinib: Oral Renal cell carcinoma
Baloxavirmarboxil Inhibit viral replication by inhibiting Cap-dependent endonuclease activity of viral polymerase Oral Single dose treatment of Acute uncomplicated influenza
Baricitinib Janus Kinase inhibitor Oral Rheumatoid Arthritis
Bictegravir Integrase inhibitor Oral HIV
Binimetinib MET tyrosine kinase inhibitor Oral BRAF V600E or V600K mutation-positive malignant melanoma
Bremelanotide Melanocortin receptor agonist subcutaneous Hypoactive sexual desire disorder in females
Brexanolone GABA-A modulator Intravenous Post partum depression
Brolucizumab VEGF inhibitor Intravitreal Neovascular Age Related Macular Degeneration
Burosumab Monoclonal antibody against FGF-23 Subcutaneous X-linked hypophosphatemia
Calaspargasepegol Asparagine specific enzyme Intravenous Acute lymphocytic leukemia
Cannabidiol Unknown Oral Lennox Gastaut syndrome Dravet Syndrome
Caplacizumab vWF-directed antibody fragment IV/SC Thrombotic Thrombocytopenic Purpura
Cemiplimab Monoclonal antibody against Programmed Death receptor (PD-1) Intravenous Squamous cell carcinoma of skin
Cenegermin Recombinant human nerve growth factor Eye drops Neurotrophic keratitis
Dacomitinib EGFR tyrosine kinase inhibitor Oral Non-small cell lung cancer with EGFR exon 19 deletion or exon 21 L858R substitution mutations
Diroximelfumarate Forms monomethylfumarate Oral Multiple sclerosis
Doravirine Non-nucleoside Reverse Transcriptase Inhibitor Oral HIV
Dupilumab MAb against IL-4R alpha. It stops signaling of IL-4 and IL-13 SC Chronic rhinosinusitis with nasal polyposis
Duvelisib Inhibitor of PI-3 kinase gamma and delta Oral Small lymphocytic lymphoma Follicular lymphoma Chronic lymphoid leukemia
Elagolix GnRH antagonist Oral Pain associated with endometriosis
Elapegademase Recombinant Adenosine deaminase enzyme Intramuscular Adenosine Deaminase-Severe Combined Immunodeficiency
Emapalumab Monoclonal antibody against IFN-gamma Intravenous Primary hemophagocyticlymphohistiocytosis
Encorafenib BRAF-Kinase Inhibitor Oral BRAF V600E or V600K mutation-positive malignant melanoma
Entrectinib Tyrosine kinase inhibitor of ROS-1 and NTRK Oral ROS-1 positive Non smallcell lung cancer and NRTK positive solid tumors
Eravacycline Inhibit protein synthesis like other tetracyclines Intravenous Complicated intra-abdominal infections
Erdafitinib FGFR Tyrosine kinase inhibitor Oral Urothelial carcinoma
Erenumab Fremanezumab Galcanezumab Monoclonal antibody against CGRP SC Migraine prophylaxis
Esketamine Non-competitive NMDA antagonist Intranasal Treatment resistant depression
Fedratinib JAK-2 Inhibitor Oral Myelofibrosis
Fostamatinib disodium hexahydrate Spleen tyrosine kinase inhibitor Oral ITP
Gilteritinib FLT3 kinase inhibitor Oral Acute myeloid leukemia
Glasdegib Hedgehog pathway inhibitor Oral Acute myeloid leukemia
Ibalizumab MAb against CD4 IV HIV
Inotersen Antisense oligonucleotide against transthyretin mRNA Subcutaneous Polyneuropathy of hereditary transthyretin-mediated amyloidosis
Istradefylline Adenosine A2 receptor antagonist Oral Off episode in Parkinsonism
Ivosidenib Isocitrate dehydrogenase 2 (IDH2) inhibitor Oral Acute myeloid leukemia with IDH2 mutation
Ixekizumab MAb against IL-17a Subcutaneous Ankylosing Spondylitis
Lanadelumab Monoclonal antibody against plasma kallikrein Subcutaneous Hereditary Angioneurotic Edema
Larotrectinib NTRK kinase inhibitor Oral Solid tumors with NTRK mutation
Lasmiditan 5HT1F agonist Oral Acute severe migraine
Lefamulin Inhibit protein synthesis in bacteria IV and oral Community acquired bacterial pneumonia
Lenvatinib VEGFR tyrosine kinase inhibitor Oral Endometrial carcinoma (with pembrolizumab)
Lofexidine Alpha 2 agonist Oral To decrease opioid withdrawal symptoms
Lorlatinib ALK kinase inhibitor Oral Non small cell carcinoma of lung
Lutetium lu 177 dotatate Peptide receptor radionuclide therapy Intravenous Gastro-entero-pancreatic neuroendocrine tumors
Megalastat Pharmacological chaperone for Alpha galactosidase Oral Fabry’s disease
Mogamulizumab Monoclonal antibody against CCR-4 Intravenous Mycosis fungoides Sezary syndrome
Moxetumomabpasudutox Monoclonal antibody against CD22 conjugated with Pseudomonas exotoxin Intravenous Hairy cell leukemia
Moxidectin Bind to Glutamate and GABA chloride channels Oral Onchocerciasis
Netarsudil + Latanoprost Netarsudil: Rho kinase inhibitor Latanoprost: PGF2 apha Topical Open angle glaucoma
Nintedanib Tyrosine kinase inhibitor of PDGFR, VEGFR, FGF, FLT-3 Oral To slow decline in pulmonary function in systemic sclerosis associated with Intersitial lung disease
Omadacycline Inhibit protein synthesis like other tetracyclines Oral Intravenous Community acquired bacterial pneumonia Acute skin and skin structure infections
Onasemnogeneabeparvovec AAV vector based gene therapy to transfer SMN gene Intravenous Spinal muscular atrophy
Patisiran Small Interfering RNA based therapy against mutant transthyretin Intravenous Polyneuropathy in patients with transthyretin mediated amyloidosis
Pegvaliase Substitute of Phenylalanine hydroxylase SC Phenylketonuria
Pembrolizumab MAb against PD-1 IV Endometrial carcinoma (with lenvatinib) Esophageal cancer Small cell lung cancer Non small cell lung cancer Renal cell carcinoma
Pexidartinib TK inhibitor of Colony Stimulating Factor 1 Receptor Oral Tenosynovial Giant Cell Tumor
Pitolisant H3 antagonist/inverse agonist Oral Narcolepsy
Plazomicin Inhibit protein synthesis like other aminoglycosides Intravenous Complicated UTI
Polatuzumabvedotin MAb against C79b component of B cell receptor Intravenous Diffuse large B cell lymphoma
Prabotulinum toxin-A Inhibit release of ACh Intramuscular Temporary improvement of glabellar lines
Pretomanid Inhibit mycolic acid synthesis Oral For XDR and MDR TB (in combination with bedaquiline and linezolide)
Prucalopride 5HT4 agonist Oral Chronic Idiopathic Constipation
Ramucirumab VEGF antagonist Intravenous Hepatocellular carcinoma
Ravulizumab C5 Complement inhibitor Intravenous Paroxysomal Nocturnal Hemoglobinuria
Relebactam Beta lactamase inhibitor Intravenous In combination with imipenem and cilastatin for intraabdominal infections and UTI
Revefenacin Anticholinergic Inhalational COPD
Rifamycin Inhibit beta subunit of RNA polymerase Oral Traveller’s diarrhea
Rimabotulinumtoxin B Inhibits release of acetylcholine Injected in salivary glands Chronic siallorhea
Risankizumab MAb against IL-23 Subcutaneous Plaque psoriasis
Romosozumab MAb against sclerostin Subcutaneous Post-menopausal osteoporosis
Ruxolitinib JAK-1 and JAK-2 inhibitor Oral Steroid resistant acute graft vs host disease
Sarecycline Inhibit protein synthesis like other tetracyclines Oral Inflammatory lesions of non-nodular moderate to severe acne
Segesterone  + ethinyl estradiol Inhibit ovulation Vaginal ring Contraception (once yearly)
Selinexor Selective inhibitor of nuclear export Oral Multiple myeloma Diffuse large B cell lymphoma
Semaglutide GLP-1 agonist Oral Type 2 diabetes mellitus
Siponimod Sphingosine-1 phsophate receptor modulator Oral Multiple sclerosis
Sodium zirconium cyclosilicate Binds to K and increase fecal excretion oral Hyperkalemia
Solriamfetol DA and NA reuptake inhibitor Oral For excessive day time sleepiness in Obstructive sleep apnea and Narcolepsy
Stiripentol Increases GABAergic activity Oral Dravet Syndrome
Tafamidismeglumine Act as chaperone to stabilize TTR protein Oral To prevent cardiomyopathy in TTR amyloidosis
Tafenoquine Free radical mediated killing of hypnozooites Oral Single dose radical cure of P. vivax malaria
Tagraxofusp Anti-CD-123 Intravenous BlasticPlasmacytoid Dendritic Cell Neoplasm
Talazoparib PARP inhibitor Oral breast cancer with a germline BRCA mutation
Tecovirimat Inhibit formation of extracellular viral forms Oral Small pox
Tenapanor NHE-3 inhibitor Oral IBS with constipation
Tildrakizumab MAb against IL-23 SC Plaque Psoriasis
Tizacaftor + ivacaftor CFTR  stimulator and potentiator Oral Cystic fibrosis
Tolvaptan Vasopressin V2 receptor antagonist Oral To slow kidney function decline in adult polycystic kidney disease
Trifarotene Retinoic acid receptor agonist Topical Acne vulgaris
Upadacitinib JAK inhibitor Oral Rheumatoid Arthritis
Venetoclax + Obinutuzumab Venetoclax: BCL-2 inhibitor Obinutuzumab: Binds to CD-20 on B cells Venetoclax: Oral Obintuzumab: IV Chronic lymphoid leukemia Small lymphocytic leukemia
Also read our blogs on high-yield topics (subject-wise) for NEET PG 2024 Preparation:
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