1 | P a g eKMCH INSTITUTE OF HEALTH SCIENCES New AND Drug RESEARCH Update (A unit of Kovai Medical Center and Hospital Limited) Coimbatore, Tamil Nadu Department of Pharmacology New Drug Update (New Drugs and Available Drugs with New Formulation) New drugs approved by FDA 1. Idecabtagene vicleucel 2. Dasiglucagon Nothing Worth Having Comes Easy 3. Ponesimod 4. Oritavancin 5. Tivozanib Series - 21 6. Dexmethylphenidate and April 2021 Serdexmethylphenidate Compiled & Edited by: Department of Pharmacology, KMCHIHSR, Coimbatore Kindly Mail Your Suggestions To: [email protected] 2 | P a g e New Drug Update 1. Idecabtagene vicleucel 2. Dasiglucagon Date of Approval: March 26, 2021 Date of Approval: March 22, 2021 Mechanism of action: B-cell Mechanism of action: Glucagon maturation antigen (BCMA)-directed analogue genetically modified autologous Indication: Severe hypoglycemia in chimeric antigen receptor (CAR) T cell diabetes patients aged 6 years and immunotherapy older Indication: Relapsed or refractory Dosage Formulation: Prefilled multiple myeloma autoinjector for subcutaneous injection Dosage Formulation: Intravenous Infusion 3. Ponesimod 4. Oritavancin Date of Approval: March 18, 2021 Date of Approval: March 12, 2021 Mechanism of action: Selective Mechanism of action: Lipoglycopeptide sphingosine-1-phosphate receptor 1 antibiotic acts by inhibiting cell wall (S1P1) modulator synthesis Indication: Relapsing Multiple Indication: Acute bacterial skin and Sclerosis skin structure Infection Dosage Formulation: Tablet Dosage Formulation: Intravenous Infusion 5. Tivozanib 6. Dexmethylphenidate and Serdexmethylphenidate Date of Approval: March 10, 2021 Date of Approval: March 2, 2021 Mechanism of action: Suppresses Mechanism of action: Prodrug of angiogenesis by inhibiting Vascular Methylphenidate acts by blocking the endothelial growth factor receptor reuptake of norepinephrine and (Tyrosine kinase inhibitor) dopamine Indication: Refractory advanced renal Indication: Attention Deficit cell carcinoma Hyperactivity Disorder Dosage Formulation: Capsule Dosage Formulation: Capsule Compiled & Edited by: Department of Pharmacology, KMCHIHSR, Coimbatore Kindly Mail Your Suggestions To: [email protected] .