Novel Drug Approvals for 2022
Drug Name:Novel Drug Approvals for 2022
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Drug Interaction:
No. Drug Name Active Ingred. Apprvl Date FDA Approved use on approved date
M- Manufacturer D-Distributor
1. QUVIVIQ Daridoexant 1/7/2022 To treat insomia
Dist by: Idorsia Pharmaceuticals US Inc. One Radnor Corporate Center, Suite 101 100 Matsonford Rd Radnor, PA 19087
Indication:
Novel Drug Approvals for 2022
(For more salient details please refer the Drug)
No. Drug Name Active Ingred. Apprvl Date FDA Approved use on approved date
M- Manufacturer D-Distributor
1. QUVIVIQ Daridoexant 1/7/2022 To treat insomia
Dist by: Idorsia Pharmaceuticals US Inc. One Radnor Corporate Center, Suite 101 100 Matsonford Rd Radnor, PA 19087
2.CIBINQO Abrocitinib 1/14/2022 To treat Refractory, moderate to severe atopic Dermatitis
For Medical Information about CIBINQO, please visit www.pfizermedinfo.com or call 1-800-438-1985. 244
3. KIMMTRAK Tebentafusptebn 1/25//22 To treat unresctable or metastatic unveal melanoma Man by: Immunocore Limited 92 Park Drive, Milton Park Abingdon, Oxfordshire United Kingdom, At: Baxter Oncology GmbH Kantstraße 2 33790 Halle/Westfalen Germany For: Immunocore Commercial LLC 181 Washington Street, Conshohocken, PA, US
4. VABYSMO Faricimabsvoa 1/28//22 To treat neovascular (wet) aged related macular degenaration and diabetic macular edema
Man by: Genentech, Inc. A Member of the Roche Group 1 DNA Way South San Francisco, CA U.S.A
5. ENJAYMO Sulimlimab- jome 2/4//22 To decrease the need for red blood transfusion due to hemolysis in cold agglutinin disease Man by: Bioverativ USA Inc. Waltham, MA 02451 A SANOFI COMPANY US Bioverativ USA Inc.
6. PYRUKYND Mitapivat 2/17/22 To treat Hemolytic Anemia in Pyrviate Kinase deficiency PYRUKYND® is a registered trademark of Angios Pharmaceuticals, Inc. Man- for and Dis by: AgiosPharmaceuticals, Inc. Cambridge, MA 02139 AG- PI-001
7. VONJO Pacritinib 2/28/22 To treat Intermediate or High Risk Primary or Secondary myelo Fibrosissis in Adults with low Platelet
Manf and mark by: CTI BioPharma Corp. 3101 Western Ave #800 Seattle, WA 98121 VONJO is a trademark of CTI BioPharma Corp.
8. ZTALMY Ganaxolone 3/18/22 To treat Seizures in Cyclic - dependent Kinase like deficiency disorder
9. OPDUALAG Mvolumab & Relatimab.rmbn 3/18/22 To treat Unresectable or Metastatic Melanoma
Man by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA U.S.
10.PLUVICTO Lutetium (177Lu) Upivotide Tetraxetan 3/23/2022 To treat Prostrate -Specific Membrane Antigen- Positive Metastatic Castration Resistent Cancer Following Resistent Cancer Following Other Therapies
Distr- by: Advanced Accelerator Applications USA, Inc. Millburn, NJ 07041 PLUVICTO is a trademark of Novartis AG and/or its affiliate
11.VIVJOYA Ostenanazole 4/26/2022 To remove the incidence of recurrent Vuvovaginal Candiadiasis with a history of Reproductive potential
Manf- for and dist by: Mycmovia Pharmaceuticals, Inc. Durham, NC 27703
12.CAMZYOS Mavacamten 4/28/2022 To treat certain classes of obstructive hypertrophic cardiomyopathy
Dist. by: MyoKardia, Inc., a wholly-owned subsidiary of Bristol Myers Squibb Brisbane, CAMZYOS is a trademark of MyoKardia, subsidiary of Bristol Myers Squibb. ©2022
13.VOQUEZNA Vanoprazin ,Amoxycillin and Clarithromycin 5/3/2022 To treat Helicobacter pylori infection
VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK are dist.by Phathom Pharmaceuticals, Inc., Buffalo Grove, IL, 60089, U.S.A. Vonoprazan Tablets are manufactured for Phathom Pharmaceuticals, Inc., Buffalo Grove, IL 60089, U.S.A. .
14.MOUNJARO Tirzepatide 5/13/2022 To imorove blood sugar control in diabetes, in adition to diet and excercise
Mark. by: Lilly USA, LLC, Indianapolis, IN 46285, USA Copyright © YYYY, Eli Lilly and Company. All rights reserved
15.VTAMA Tapinarof 5/23/2022 To treat plaque psoriasis
Mark. by: Dermavant Sciences Inc., 3780 Kilroy Airport Way, Long Beach, CA 90806 VTAMA is a registered trademark of Dermavant Sciences, GmbH or its affiliates. U.S. Patents:
16. AMVUTTRA Vutrisiran 6/13/2022 To treat polyneuropathy of heridirary transthyretin- medicated amyloidosis
Man- for: Alnylam Pharmaceuticals, Inc., Cambridge, MA 02142. AMVUTTRA is a pending trademark of Alnylam Pharmaceuticals, Inc.
17.XENOPYZME Olipudase alfa 8/31/2022 To treat generalized pustular psoriasis flares
XENPOZYME is discontinued. Man- by: Genzyme Corporation 450 Water Street Cambridge, MA 02141 .
18.SPEVIGO Spesolimab-sbzo 9/12022 To treat generlized postular psoriasis flares
Man- by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA . US License Number 2006 Licensed from: Boehringer Ingelheim International GmbH, Ingelheim, Germany. SPEVIGO is a registered trademark of and used under license from Boehringer Ingelheim International. .
19. DAXXIFY DaxibotulinumotoixnA-lanm 9/7/2022 To treat moderate- to-severe glabellar lines associated with corrugator and/or procerus mucle activity
Man- by: Revance Therapeutics, Inc. Newark, CA DAXXIFY is a trademark of Revance Therapeutics, Inc. .
20. SOTYKYU Deucravactitinib 9/9/2022 To treat moderate severe plague psoriasis
SOTYKTU.- Dist. by: Bristol-Myers Squibb Company Princeton, New Jersey 08543 USA
21.ROLVEDON Eflapegrastim 9/9/2022 To decrease the incidence of infection in patients with non- myeloid malignancies receiving mylosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia
Rolvedon- Man-by: Spectrum Pharmaceuticals, Inc Von Karman Avenue, Suite 700 Suite 700 Irvine, .CA 92612 USA
22. TERILIVAZ Terlipressin 9/14/2022 To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function
TERLIVAZ- Dist by: Mallinckrodt Hospital Products Inc. Von Karman Avenue, Suite 700 .
23. ELUCIREM Gadopiclenol 9/21/2022 To detect and visulalize lesions, together with MRI, with abnormal vascularity in the central nervous system and the body.
ELUCIREM.. Man- by Liebel-Flarsheim Company LLC, 8800 Durant Road, Raleigh, North Carolina (NC) 27616-3104, USA - Dis- by Guerbet LLC 214 Carnegie Center, Suite 300, Princeton, NJ 08540, USA
24. OMLONTI Oomidenepag isopropyl ophthalmic solution 9/22/2022 To reduce elevated introcular pressure in patients with open- angle glacoma or ocular hypertension
Omlonti (omidenepag isopr Man- for: Santen Inc. Man- by: Woodstock Sterile Solutions, Inc. Dist- by: Santen Inc. 6401 Hollis Street, Suite 125 Emeryville, CA 94608 United States
25. RELYVRIO Sodium phenyl butyrate/taurusodiol 9/29/2022 To treat amytrophic latera sclerosis (ALS)
Man- for and Dist.- by: Amylyx Pharmaceuticals, Inc., 43 Thorndike Street, Cambridge, MA 02141 ©2022 Amylyx Pharmaceuticals, Inc. RELYVRIO™ are trademarks of Amylyx Pharmaceuticals, Inc
26.LYGOBI Futibatinib 9/30/2022 To treat intrahepatic cholanfiocarcinoma harboring fibroblast growth factor 2 (FGFR2) gene fusions or other
Manufactured for: Taiho Pharmaceutical Co., Ltd. Japan Distributed by: Taiho Oncology, Inc. Princeton, NJ 08540 USA LYTGOBI is a trademark of Taiho Pharmaceutical Co., Ltd. U.S. Patent Nos. 9,108,973 and 10,434,103 © 2022 Taiho Oncology, Inc. All rights reserved.
27. IMJUDO Tremelimumab 10/21/2022 To treat unresctable hepatocellular varconima
Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured By: AstraZeneca AB Södertälje, Sweden SE-15185 US License No. 2059 IMJUDO® is a registered trademark of AstraZeneca group of companies. ©AstraZeneca 2022
28.TECVAYLI Teclistamab-cqyv 10/25/2022 To treat relapsed or refractory multiple myloma among adults who have received at least four specific lines of therrapy.
TECVAYL- - Manf-by: Janssen Biotech, Inc. Horsham, PA 19044 U.S. License Number 1864
29. ELAHERE Mirvetuximab soravtansine-gynx 11/14/2022 To treat patients with ovarian cancer that is resistent to platinium theraphy.
Manufactured by: ImmunoGen, Inc. Waltham, MA 02451 1-781-895-0600 U.S. ELAHERE is a trademark of ImmunoGen, Inc. ©2022 ImmunoGen, Inc.
30. TZIELD Teplizumab-mzwv 11/18/2022 To delay the onset of stage 3 type diabetes.
Man-by: Provention Bio, Inc. 55 Broad Street Red Bank, NJ 07701 U.S. TZIELD is a trademark of Provention Bio, Inc. Copyright © 2022, Provention Bio, Inc. All rights reserved.
31. REZLIDHIA Olutasidenib 12/1/2022 To treat adults with relapsed or refractoy acute myeloid leukemia with susestible isocitrate dehydrogenase- 1 (IDH!) mutation.
Man- Mirati Therapeutics, Inc. 3545 Cray Court San Diego, CA 92121, U.S.A. © 2022 Mirati Therapeutics, Inc. All Rights Reserved
32.KRAZATI Adagrasib 12/12/2022 To treat KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer in adults who have received one prior systemic therapy.
KRAZATI-. (adagrasib- Man-for: Mirati Therapeutics, Inc. 3545 Cray Court San Diego, CA 92121, U.S.A. © 2022 Mirati Therapeutics, Inc. All Rights Reserved
33. SUNLENCA Lenacpavir 12/22/2022 To treatadults with HIV infections cannot be succesfully treated with other available treatments due to resistence,intolerance, or safety considerations.
SUNLENCA is a trademark of Gilead Sciences, Inc., or its related companies. Gilead Sciences, Inc. All rights reserved.
34.LUNSUMIO Mosunetuzmab-axgb 12/22/2022 To treat adults with relapsed or refractory follicular lymphoma,a type of non-Hodgkin lympoma.
Man-by: Genentech, Inc. A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080-4990 U.S. License No.: 1048' LUNSUMIO is a trademark of Genentech, Inc. ©2022 Genentech, Inc.
35. XENOVIEW Hyperpolarized Xe-129 12/23/2022 To evaluate pulmonary function and imaging.
Man- for: Polarean, Inc. 2500 Meridian Parkway, Suite 175 Durham, NC 27713 44-XENOVIEWTM is a trademark of Polarean, Inc.
36. BRIUMI Ublituximab-xiiv 12/28/2022 To treat relapsing . forms of multiple sclerosis.
BRIUMVI-. Man-by : TG Therapeutics, Inc. 3020 Carrington Mill Blvd Morrisville, NC 27560 U.S. License No. 2090 .
37. NEXOBRID Anacaulase-bcdb 12/28/2022 To remove eschar in adults with deep partial thickness or full thickness thermal burns.
Dist- by: Vericel Corporation 64 Sidney Street Cambridge, MA 02139 Man- by: MediWound LTD 42 Hayarkon Street, Yavne 8122745 Israel U.S. License NEXOBRID® is a registered trademark of MediWound LTD
