Novel Drug Approvals for 2018
Drug Name:Novel Drug Approvals for 2018
List Of Brands:
Indication Type Description:
Indication
Indication:
Novel Drug Approvals for 2018
(For more salient details please refer the Drug)
No. Drug Name Active Ingred. Apprvl Date FDA Approved use on approved date
M- Manufacturer Distributor-
1.Luthathera Lutetium Lu 177 Jan 2018 To treat a type of cancer that affects dotatate the pancreas or gastrointestinal tract called gastroentereropancreatic neuroendocrine tumors (GEP-NETs)
BIKTARVY is a trademark of Gilead Sciences, Inc.,
4.Erleada Apalutamide Feb 2018 To treat a certain type of prostrate cancer using novel clinical trial endpoint
M by: Janssen Ortho LLC Gurabo, PR 00778 M for: Janssen Products, LP Horsham, PA 19044
6.IIumya Tildrakizumab Mar 2018 To treat adults with moderate-to- severe plaque psoriasis who are candidates for systemic therapy or thrombocytopenia (ITP)
7. Tavakisse Fosatamatinib Apr 2018 To treat thrombocytopenia in adult patients with persistent or chronic immune thrombocytopenia (ITP)
M for: Rigel Pharmaceuticals, Inc., 1180 Veterans Blvd., South San Francisco, CA 94080 USA M by: Patheon Whitby, 111 Consumers Drive, Whitby, Ontario L1N 525 Canada © Rigel Pharmaceuticals, Inc.
8.Crysvita Burosumab-twza Apr 2018 To treat adults and children ages 1 year and older with x-linked hyphophoshatemia(XLH), a rare, inherited form of rickets
M by: Ultragenyx Pharmaceutical Inc. Novato, CA 94949 US A D by: Ultragenyx Pharmaceutical Inc. Novato, CA 94949 USA
9.Akynzeo Fosnetupitant Apr 2018 To prevent acute delayed nausea and and palonesetron vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy
M by : Helsinn Birex Pharmaceuticals, Dublin, Ireland for Helsinn Healthcare SA, Switzerland D by Helsinn Therapeutics (U.S.), Inc., Iselin, NJ 830, AKYNZEO is a registered trademark of Helsinn Healthcare SA, Lugano, Switzerland
10.Lucemyra Lofexidine May 2018 For the non-opiod treatment for hydrochloride management of opiod withdrawal symptoms in adults
D by: US WorldMeds, LLC 4441 Springdale Road Louisville, KY 40241 Under License from Britannia Pharmaceuticals Limited. US WorldMeds, LLC is the exclusive licensee and distributor of LUCEMYRA™
11.Amovig Ernumab-aooe May 2018 For the preventive treatment of migraine
M by: Amgen Inc. One Amgen Center Drive Thousand Oaks, CA 91320-1799 USA Mk by: Amgen Inc. (Thousand Oaks, CA 91320), and Novartis Pharmaceuticals Corporation (East Hanover, NJ 07936)
12.Lokemia Sodium May 2018 To treat hyperkalemia Zirconium Cyclosilicate
M by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850
13.Doptelet Avatromnopag May 2018 To treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure
M for: AkaRx, Inc., Durham, North Carolina 27707 D and Mk by Dova Pharmaceuticals, Inc., Durham, North Carolina 27707
14.Pallynziq Pegvaliase-pqpz May 2018 To treat adults with a rare and serious genetic disease known as phenylketonuria(PKU)
M by: BioMarin Pharmaceutical Inc. Novato, CA 94949 US
15.Olumiant Baricitinib May 2018 To treat modrately to severely active rheumatoid arthiritis
Mk by: Lilly USA, LLC, Indianapolis, IN 46285, USA Eli Lilly and Company.
16.Moxidectin Moxidectin June 2018 To treat onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older
NA-
17.Epidiolex Cannabidiol June 2018 To treat rare,severe forms of epilepsy
Mk by Greenwich Biosciences, Inc., Carlsbad, CA 92008 USA
18. Zemdril Plazomicin June 2018 To treat adults with complicated urinary tract infections
M for: Achaogen, Inc. South San Francisco, CA 94080
19.Mektovi Binimetinib June 2018 To treat unresectable or metastatic melanona
D by: Array BioPharma Inc. 3200 Walnut Street Boulder, CO 80301 MEKTOVI® is a registered trademark of Array BioPharma Inc. in the United States and various other countries.
20. Braftovi Encorafenib June 2018 To treat unresectable or metastatic melanona
D by: Array BioPharma Inc. 3200 Walnut Street Boulder, CO 80301 BRAFTOVI™ is a trademark of Array BioPharma Inc.
21.TPOXX Tecovirimat July 2018 To treat small pox
M by: Catalent Pharma Solutions,1100 Enterprise Drive,Winchester, KY 40391 D by: SIGA Technologies, Inc. 4575 SW Research Way,Corvallis, OR 97333
22. Tibsovo Ivosidenib July 2018 To treat patients with relapsed or refractory acute myeloid leukemia
M for and Mk by: Agios Pharmaceuticals, Inc. Cambridge, MA 02139 TIBSOVO® is a registered trademark of Agios Pharmaceuticals, Inc..
23.Krintafel Tafenoquine July 2018 For the radical cure (prevention of relapse) of Plasmodium vivax malaria
M by -GlaxoSmithKline Research Triangle Park, NC 27709 ©2018 GSK group of companies or its licensor. KFL:1PI Trademark is owned by or licensed to the GSK group of companies.
24.Orilissa Elagolixx sodium July 2018 For the management of moderate to severe pain associted with endometriosis
M by AbbVie Inc. North Chicago, IL 60064 © 2018 AbbVie Inc. All rights reserved. 03-B517 July 2018
25.Omegaven Fish Oil July 2018 As a sourse of calories and fatty Triglycerides acids in pediatric patients with parentral nutriotion-associated cholestasis
M by: Graz, Austria www.fresenius-Kabi.com Fresenius Kabi and Omegaven are registered trademarks of Fresenius Kabi.
26.Multpleta Lustrobopag July 2018 To treat thombocytopenia in adult patients who are scheduled to undergo a procedure
MULPLETA is a registered trademark of Shionogi & Co., Ltd. M for Shionogi Inc., Florham Park, NJ 07932. M by Quotient Sciences ? Philadelphia, LLC, Boothwyn, PA 19061.
27. Poteligeo Mogamulizumab Aug 2018 To treat two rare types of no-Hodgkin l -pkkc lymphoma
OTELIGEO® (mogamulizumab-kpkc) M by: Kyowa Kirin, Inc. Bedminster, NJ 07921 US
28. Onpattro Patisiran Aug 2018 To treat the polyneuropathy of heriditary transthyretin- mediated amyloidosis in adult patients
M for: Alnylam Pharmaceuticals, Inc. 300 Third Street, Cambridge, MA 02142 By: Ajinomoto Althea, Inc. 11040 Roselle Street, San Diego, CA 92121
29.Anovera Segesterone Aug 2018 New vaginal ring used to prevent acetate and pregnancy for an entire year ethyl estradiol vaginal system
M for: Population Council One Dag Hammarskjold Plaza New York, NY 10017 United states
30.Galafold Migalastat Aug 2018 To treat adults with Fabry disease
M for: Amicus Therapeutics U.S., Inc. 1 Cedar Brook Drive Cranbury, NJ 08512 GALAFOLD™ is a trademark of Amicus Therapeutics, Inc.
31.Diacomit Stiripentol Aug 2018 To treat seizures associated with Dravet syndrome in npatients 2 years of age and older taking clobazam
DIACOMIT Capsules and DIACOMIT Powder for Suspension M by: BIOCODEX 1, avenue Blaise Pascal 60000 BEAUVAIS France
32.Oxervate Cenegermin Aug 2018 To treat neurotrophic keratitis -bkbj
M by Dompé farmaceutici S.p.A. Via Campo di Pile 67100 L’Aquila, Italy U.S. License No. 2074
33. Takhzyro Tanadelumab Aug 2018 To treat types I and II hereditary angioedema
NA
34. Xerava Eravacycline Aug 2018 To treat complicated intr-abdominal infections in patients 18 years and older
D by:Tetraphase Pharmaceuticals, Inc. 480 Arsenal Way, Ste 110 Watertown, MA 02472 XERAVA™ is a trademark of Tetraphase Pharmaceuticals, Inc. .
35. Pifeltro Doravirine Aug 2018 To treat HIV- 1 infection in adult patients
M-by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
36.Lumoxitil Moxetumomab Sep 2018 To treat hairy cell leukemia pasudotox-tdfk
D by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 M by: AstraZeneca AB, Södertälje, Sweden SE-151 85
37.Ajovy Fremanezumab Sep 2018 For the preventive treatment of -vfrm migraine in adults
M by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 .
38.Copikta Duvelisib Sep 2018 To treat relapsed or refractory chronic lymphocyctic leukemia and follicular lymphoma
M for: Verastem, Inc. 117 Kendrick Street Suite 500 Needham, MA 02494
39.Emgality Galcanezumab Sep 2018 For the preventive treatment of -gnlm migraine in adults
Eli Lilly and Company, Indianapolis, IN 46285, USA US License Number 1891
40. Vizimpro Dacomitinib Sep 2018 To treat metastatic non-small-cell lung cancer
Distributed by Pfizer Lab USA
41.Libtayo Cemilpimab Sep 2018 To treat cutaneous cell carcinoma -rwlc carcinoma (CSCC)
M by: Regeneron Pharmaceuticals, Inc. 777 Old Saw Mill River Road, Tarrytown, NY 10591-6707 .U.S. License No. 1760
Mk by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591) and sanofi-aventis U.S. LLC (Bridgewater, NJ 08807)
42.Seysara Sarecycline Oct 2018 To treat inflammatory lesions of non- modular moderate to severe acne vulgaris in patients 9 years of age and older
D by: Allergan USA, Inc. Madison, NJ 07940 USA
43.Nuzyra Omadacycline Oct 2018 To treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections
D by: Paratek Pharmaceuticals, Inc. Boston, MA, USA
44.Revcovi Elapegademase Oct 2018 To treat Adenosine Deaminase-Severe - lvir Combined Immunodefdiciency (ADA-SCID)
M by: Leadiant Biosciences Inc., Gaithersburg, MD 20878, USA, U.S. License No. 2073 at Exelead Inc., 6925 Guion Rd, Indianapolis, IN 46268, USA
45.Tegsedi Inotersen Oct 2018 To treat ployneuropathy of herideritary transthyretin- mediated amyloidosis in adults
D by: Ionis Pharmaceuticals, Inc. Carlsbad, CA 92010 TEGSEDI is a trademark of Ionis Pharmaceuticals, Inc.
46. Talzenna Talazoparib Oct 2018 For the treatment of locally advanced or metastic breast cancer patients with a germine BRCA mutation
This product’s label may have been updated. For current full prescribing information, please visit www.talzenna.com. LAB-1271-0.6. Contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088
47. Xofluza Baloxvir marboxil Oct 2018 For the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours
48. Lorbrena Lorlatinib Nov 2018 To treat patients with anaplastic lymphoma kinase (ALK) -positive metastatic non-small lung cancer
For full prescribing information, please visit www.LORBRENA.com. LAB-1162-0.11 Product of Pfizer USA
49.Yulpeiri Revefenacin Nov 2018 To treat patients with chronic obstructive pulmonary disease(COPD)
The brands listed are trademarks of their respective owners. Licensed from: Manufactured for: Theravance Biopharma M for: Theravance Biopharma Ireland Limited Mylan Specialty L.P. Morgantown, WV 26505 USA
50. Aemcolo Rifamycin Nov 2018 To treat traveler'd diarrhea
M for: Cosmo Technologies, Ltd. Dublin, Ireland M by: Cosmo S.p.A. Lainate, Milan, Italy Made in Italy D by: Aries Pharmaceuticals, Inc. 9276 Scranton Rd. Suite 600 San Diego, CA 92121 (USA) 888-ARIES-08 (888-274-3708)
51.Gamifant Emapaluma Nov -2018 To treat primary hemophagocytosis -lzsg (HLH)
M by: Novimmune SA Geneva, Switzerland U.S. License Number 2082 D by: Sobi Inc. 890 Winter Street Waltham, MA 02451 M at: Patheon Italia S.p.A 2° Trav. SX Via Morolense, 5 03013-Ferentino Italy Product of the United Kingdom
52.Daurismo Glasdegib Nov 2018 To treat newly-diagnosed acute myeloid(AML) in adult patients
NA
53. Vitrakvi Larotrectinib Nov 2018 To treat patients whose cancers have a specific genetic feature (biomarker)
M for: Loxo Oncology, Inc. Stamford, CT 06901 Reference ID: 4354324
54. Firdapase Amifampridine Nov 2018 To treat patients whose cancers have a specific genetic feature
D by Catalyst Pharmaceuticals, Inc., Coral Gables, FL 33134. FIRDAPSE is a trademark of Catalyst Pharmaceuticals, Inc.
55.Xospata Gilteritnib Nov 2018 To treat patients who have relapsed or refractory acute myeloid leukemia (AML)
D by:Astellas Pharma US, Inc. Northbrook, Illinois 60062 XOSPATA® is a registered trademark of Astellas Pharma Inc. ©2018 Astellas Pharma US, Inc. 17G072-GL
56.Motegrity Prucalopride Dec 2018 To treat chronic idiopathic constipation
M for: Shire US Inc. 300 Shire Way Lexington, MA 02421 For more information go to www.motegrity.com or call 1- 800-828-2088
57.Asparias Calaspargase Dec 2018 To treat acute lymphoblastic leukemia pegol-mknl (ALL) in pediatric and young adult patients age 1 month to 21 years
58.Elzonris Tagraxofusp Dec 2018 To treat blastic plasmacytoid -erzs dendritic cell neoplasm(BPBCN)
M and D by: Stemline Therapeutics, Inc. New York, NY 10022 US License No. 2088
59.Ultomiris Ravulizumab Dec 2018 To treat paroxysmal nocturnal hemoglobinuria (PNH)
M by: Alexion Pharmaceuticals, Inc. 121 Seaport Boulevard Boston, MA 02210 USA US License Number 1743
