Novel Drug Approvals for 2023
Drug Name:Novel Drug Approvals for 2023
List Of Brands:
Indication Type Description:
Indication
Indication:
No. Drug Name Active Ingred. Apprvl Date FDA Approved use on approved date
M- Manufacturer D-Distributor
1.LEGEMBI Lecanemab-irmb 1/6/2023 To Alzheimer's disease
Manufactured by: Eisai Inc. Nutley, NJ 07110 U.S. License No. 1862 LEQEMBI is a trademark of Eisai R&D Management Co., Ltd. © XXXX Eisai Inc. and Biogen
2.BENZAVVY Bexagliflozin 1/20/2023 To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and excercise
Distributed by: TheracosBio, LLC 225 Cedar Hill Street, Suite 200 Marlborough, MA 01752 USA BRENZAVVY is a trademark of TheracosBio, LLC Other brands listed are the trademarks of their respective owners and are not trademarks of TheracosBio, LLC Copyright © 2023 TheracosBio, LLC All rights reserved. Reference ID: 5112979
3. JAYPIRCA Pirtobrutinib 1/27/2023 To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor
JAYPIRCA-Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA Copyright © 2023, Eli Lilly and Company. All rights reserved. JAY-0001-USPI-202301DD Reference ID: 5116752 PATIENT INFORMATION
4. ORSERDU Elacestrant 1/27/2023 To treat receptor positive, human epidermal growth receptor-2-negative ESRI-1 - mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy
ORSERDU is a trademark of the Menarini Group. ©Stemline Therapeutics, Inc., a Menarini Group company Manufactured for: Stemline Therapeutics, Inc., New York, NY 10022
5. JESDUVROQ Daprodustat 2/1/2023 To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months
JESDUVROQ-. Trademarks are owned by or licensed to the GSK group of companies. Manufactured by GlaxoSmithKline Durham, NC 27701 ©2023 GSK group of companies or its licensor. JDV:1P
6. LAMZEDE Velmanase alfa-tycv 2/1/2023 To treat non-central nervous system manifestations of alpha- mannosidosis
Manufactured by: Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italy U.S. License No. 2245 Manufactured at: Patheon Italia S.p.A., Ferentino FR, Italy, 03013 Manufactured for: Chiesi USA, Inc., Cary NC, 27518, USA. Product of Germany. LAMZEDE is a registered trademark of Chiesi Farmaceutici S.p.A. CTVA-001-0222-00
7.FILSPARI Sparsentan 2/17/23 To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression
Distributed by Travere Therapeutics, Inc., San Diego, CA 92130 FILSPARI is a registered trademark of Travere Therapeutics, Inc.
8.SKYCLARYS Omaveloxone 2/28/2023 To treat Friedrich's ataxia
Manufactured for Reata Pharmaceuticals, Inc., Plano, TX 75024 USA SKYCLARYS is a trademark of Reata Pharmaceuticals Holdings, LLC, used under license by Reata Pharmaceuticals, Inc., Plano, TX 75024 USA Copyright© 2023, Reata Pharmaceuticals, Inc., Plano, TX 75024 USA All rights reserve
9. ZAVZPRET Zavegepant 3/9/2023 To treat migraine
10.DAYBUE Trofintide 3/10/2023 To treat Rett syndrome
Marketed by: Acadia Pharmaceuticals Inc. San Diego, CA 92130 USA DAYBUE is a trademark of Acadia Pharmaceuticals Inc. ©2023 Acadia Pharmaceuticals Inc. All rights reserved
11. ZYNY Retifanlimab-dlww 3/22/2023 To treat metastatic or recurrent locally advanced market cell Carcinoma 12.
ZYNYZ -. Manufactured by: Incyte Corporation Wilmington, DE 19803 U.S. License No. 2228 ZYNYZ and the ZYNYZ logo are trademarks of Incyte. © 2023 Incyte Corporation. All rights reserved.
12.REZZAYO Rezafungin 3/22/2023 To treat carcinoms and invasive candifasis
13. JOENJA Lenioliib 2/24/2023 To treat activated Phosphinositde delta syndrome
