New FDA Approved Drugs in 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

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