Novel Drug Approval by FDA (January 2022- March 2022)

List of drugs approved by FDA in 2022 (from January 2022 to March 2022)

Drug Name	Active Ingredient	Company	FDA approved uses	Approval Date	Extra information
Quviviq	Daridorexant	Indorsia Ltd.	To treat insomnia	January 7, 2022	It is a dual orexin receptor antagonist. Tablet- 25 mg, 50 mg.
Cibinqo	Abrocitinib	Pfizer Inc.	For Atopic dermatitis	January 14, 2022	JAK (Janus Kinase)1 inhibitor. Tablet- 50, 100 and 200 mg.
Ryaltris	Mometasone furoate and olapatdine HCL	Glenmark Pharmaceutical Inc.	Seasonal allergic rhinitis in patients of age 12 years and older.	January 13, 2022	Mometasone furoate is corticosteroid and olapatadine is histamine (H1) receptor inhibitor. Nasal spray
Kimmtrak	Tebentafusp-teben	Immunocore	For unresectable or metastatic uveal melanoma	January 25, 2022	Bispecific gp-100 peptide-HLA-directed Cd3 T cell engager. Injection.
Vabysmo	Faricimab-svoa	Genetech	To treat neovascular age-related macular degeneration and diabetic macular edema.	January 28, 2022	It is a bispecific antibody which inhibits VEGF (vascular endothelial growth factor) and angiopoietin-2 pathway. Intravitreal injection.
Slikevax	Moderna Covid-19 vaccine	Moderna, Inc.	Prevention of COVID-19	January 31, 2022	mRNA vaccine for active immunization against COVID-19.

Enjaymo	Sutimlimab-jome	Sanofi	To decrease need for transfusion of red blood cells due to hemolysis in cold agglutinin disease.	February 4, 2022	Classical complement inhibitor. For intravenous use.
Fleqsuvy	Baclofen	Azurity Pharmaceutical Inc.	For spasticity	February 4, 2022	GABA agonist. Oral suspension.
Pyrukynd	Mitapivat	Agios pharmaceutical Inc.	To treat hemolytic anemia. In pyruvate kinase deficiency	February 17, 2022	Activates pyruvate kinase. Tablet- 5, 20 and 50 mg.
Norliqva	Amlodipine besylate	CMP Pharma, Inc.	For hypertension in patients 6 years and older.	February 24, 2022	Amlodipine is calcium channel blocker. First FDA approved liquid solution of amlodipine.
Releuko	Filgrastim- ayow	Kashiv Biosciences LLC.	Neutropenia	February 25, 2022	Leukocyte growth factor. SC (subcutaneous) or IV use.
Carvykti	Ciltacabtageneautoleucel	Janssen Biotech Inc.	Multiple myeloma	February 28, 2022	Genetically modified autologous T-cell immunotherapy which is BCMA directed. Suspension of IV infusion.
Vonjo	Pacritinib	CTI Biopharma Corp.	Primary or secondary myelofibrosis in adults with low platelet count.	February 28, 2022	JAK 2/FLT3 multikinase inhibitor. Capsules- 100 mg

Adlarity	Donepezil	Corium Inc.	Mild, moderate, and severe dementia in Alzheimer’s disease.	March 11, 2022	Acetylcholinesterase inhibitor. First and only once-weekly transdermal patches.
Nasonex 24 Hour Allergy	Mometasone furoate hydrate	Perrigo Company Plc	Allergic Rhinitis.	March 11, 2022	It is a corticosteroid. Nasal spray available OTC.
Ztalmy	Ganaxolone	Marinus Pharmaceuticals Inc.	To treat seizure in CDKL-5 deficiency disorder (CDD).	March 18, 2022	Neuroactive steroid GABA- A receptor positive modulator. Oral suspension
Opdualag	Nivolumab and ritalumab	Bristol Myers Squibb	Unresectable or metastatic melanoma.	March 18, 2022	Nivolumab is PD-1 (programmed death receptor-10 blocking antibody and ritalumab is LAG-3 (lymphocyte activation gene-3) blocking antibody. IV injection
Xelstrym	Dextroamphetamine	Noven pharmaceuticals Inc.	For ADHD (attention deficit hyperactivity disorder).	March 22, 2022	CNS stimulant. Transdermal system
Hyftor	Sirolimus	Nobelpharma America LLC.	Facial angiofibroma associated with tuberous sclerosis.	March 22, 2022	mTOR inhibitor immunosuppressant. Topical gel
Pluvicto	Lutetium (177 lu) vipivotide tetraxetan	Novartis	Prostate cancer	March 23, 2022	Radioligand therapeutic agent. IV injection
Tlando	Tesotosterone	Antares Pharma Inc.	For hypogonadism in male	March 28, 2022	Testosterone is androgen. Available as capsule.