new drugs of … new drugs of 2017with table... · astrazeneca pharmaceuticals lp add-on...

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New Drugs of 20171,3,5,7,10,14,16,20,22,24,26,28,30,32,34,36,38,40,41,43,45-86 Brand Name/ Generic Name/

Company

Approved Indication

Aliqopa

Copanlisib Dihydrochloride

Intravenous Injection

Bayer HealthCare

Pharmaceuticals Inc.

Treatment of adult patients with relapsed follicular lymphoma

(FL) who have received at least two prior systemic therapies

Alunbrig

Brigatinib Tablets

ARIAD Pharmaceuticals, Inc.

Treatment of patients with anaplastic lymphoma kinase

(ALK)-positive metastatic non-small cell lung cancer

(NSCLC) who have progressed on or are intolerant to

crizotinib

Austedo

Deutetrabenazine Tablets

Teva Pharmaceuticals USA, Inc.

Treatment of chorea associated with Huntington’s disease

Bavencio

Avelumab Intravenous

Injection

EMD Serono, Inc.

Treatment of adults and pediatric patients 12 years and older

with metastatic Merkel cell carcinoma (MCC) and locally

advanced or metastatic urothelial carcinoma (UC) who have

disease progression during or following platinum-containing

chemotherapy or have disease progression within 12 months

of neoadjuvant or adjuvant treatment with platinum-

containing chemotherapy

Baxdela

Delafloxacin Meglumine

Tablets and Intravenous

Injection

Melinta Therapeutics, Inc.

Treatment of acute bacterial skin and skin structure infections

caused by susceptible isolates of gram-positive and negative

organisms

Benznidazole

Benznidazole Tablets

Exeltis USA, Inc

Treatment of Chagas disease (American trypanosomiasis),

caused by Trypanosoma cruzi, in pediatric patients 2 to 12

years of age

Besponsa

Inotuzumab Ozogamicin


Wyeth Pharmaceuticals, Inc

Treatment of adults with relapsed or refractory B-cell

precursor acute lymphoblastic leukemia (ALL)

Brineura

Cerliponase Alfa

Intraventricular Injection

BioMarin Pharmaceutical Inc

Indicated to slow the loss of ambulation in symptomatic

pediatric patients 3 years of age and older with late

infantile neuronal ceroid lipofuscinosis type 2 (CLN2),

also known as tripeptidyl peptidase 1 (TPP1) deficiency

Bevyxxa

Betrixaban Capsules

Portola Pharmaceuticals, Inc.

Prophylaxis of venous thromboembolism in adult patients

hospitalized for an acute medical illness who are at risk for

thromboembolic complications due to moderate or severe

restricted mobility and other risk factors for VTE.

Calquence

Acalabrutinib Capsules

Treatment of adult patients with mantle cell lymphoma

(MCL) who have received at least one prior therapy

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AstraZeneca Pharmaceuticals LP

Cyltezo

Adalimumab-adbm

Subcutaneous Injection

Boehringer Ingelheim

Pharmaceuticals, Inc.

Treatment of Rheumatoid Arthritis, Juvenile Idiopathic

Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Adult

Crohn’s Disease, Ulcerative Colitis, and Plaque Psoriasis

Dupixent

Dupilumab Subcutaneous

Injection

Regeneron Pharmaceuticals, Inc.

Treatment of adult patients with moderate-to-severe atopic

dermatitis whose disease is not adequately controlled with

topical prescription therapies or when those therapies are

not advisable.

Emflaza

Deflazacort Tablets and Oral

Suspension

Marathon Pharmaceuticals, LLC

Treatment of Duchenne muscular dystrophy in patients 5

years of age and older

Fasenra

Benralizumab Subcutaneous

Injection


Add-on maintenance treatment of patients with severe

asthma aged 12 years and older, and with an eosinophilic

phenotype

Giapreza

Angiotensin II Intravenous

Infusion

La Jolla Pharmaceutical

Company

Vasoconstrictor to increase blood pressure in adults with

septic or other distributive shock

Haegarda

C1 Esterase Inhibitor

[Human] Subcutaneous

Injection

CSL Behring LLC

Routine prophylaxis to prevent Hereditary Angioedema

(HAE) attacks in adolescent and adult patients

Hemlibra

Emicizumab-kxwh

Subcutaneous Injection

Genentech, Inc

Routine prophylaxis to prevent or reduce the frequency of

bleeding episodes in adult and pediatric patients with

hemophilia A (congenital factor VIII deficiency) with

factor VIII inhibitors

Heplisav-B

Hepatitis B Vaccine

(Recombinant), Adjuvanted

Solution for Intramuscular

Injection

Dynavax Technologies

Corporation

Prevention of infection caused by all known subtypes of

hepatitis B virus in adults 18 years of age and older.

Idhifa

Enasidenib Mesylate Tablets

Celgene Corporation

Treatment of adult patients with relapsed or refractory

acute myeloid leukemia (AML) with an isocitrate

dehydrogenase-2 (IDH2) mutation as detected by an FDA-

approved test


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Imfinzi

Durvalumab Intravenous

Injection


Treatment of patients with locally advanced or metastatic

urothelial carcinoma who have disease progression during

or following platinum-containing chemotherapy or have

disease progression within 12 months of neoadjuvant or

adjuvant treatment with platinum-containing chemotherapy

Ingrezza

Valbenazine Tosylate Capsules

Neurocrine Biosciences, Inc.

Treatment of tardive dyskinesia.

Ixifi

Infliximab-qbtx Intravenous

Injection

Pfizer, Inc.

Treatment of Crohn’s Disease, Pediatric Crohn’s Disease,

Ulcerative Colitis, Rheumatoid Arthritis in combination

with methotrexate, Ankylosing Spondylitis, Psoriatic

Arthritis, and Plaque Psoriasis

Kedrab

Rabies Immune Globulin

Intramuscular Injection

Kedrion Biopharma Inc.

Passive, transient post-exposure prophylaxis (PEP) of

rabies infection, when given immediately after contact with

a rabid or possibly rabid animal

Kevzara

Sarilumab Subcutaneous

Injection

Sanofi-Aventis U.S. LLC

Treatment of adult patients with moderately to severely

active rheumatoid arthritis who have had an inadequate

response or intolerance to one or more disease-modifying

antirheumatic drugs

Kisqali

Ribociclib Succinate Tablets

Novartis Pharmaceuticals

Corporation

Indicated in combination with an aromatase inhibitor as

initial endocrine-based therapy for the treatment of

postmenopausal women with hormone receptor (HR)-

positive, human epidermal growth factor receptor 2

(HER2)-negative advanced or metastatic breast cancer

Kymriah

Tisagenlecleucel


Corporation

Treatment of patients up to 25 years of age with B-cell

precursor acute lymphoblastic leukemia (ALL) that is

refractory or in second or later relapse

Macrilen

Macimorelin Oral Solution

Aeterna Zentaris

Indicated for the diagnosis of adult growth hormone

deficiency

Mavyret

Glecaprevir and Pibrentasvir

Tablets

AbbVie, Inc

Treatment of patients with chronic HCV genotype 1, 2, 3,

4, 5 or 6 infection without cirrhosis and with compensated

cirrhosis as well as patients with HCV genotype 1

infection, who previously have been treated with a regimen

containing an HCV NS5A inhibitor or an NS3/4A protease

inhibitor, but not both.

Mepsevii

Vestronidase-Alfa-vjbk

intravenous Injection

Ultragenyx Pharmaceutical Inc.

Treatment of Mucopolysaccharidosis VII (MPS VII, Sly

syndrome) in pediatric and adult patients

Mvasi

Bevacizumab-awwb

Intravenous Solution

Metastatic colorectal cancer, Metastatic colorectal cancer,

Non-squamous non-small cell lung cancer, Glioblastoma,

Metastatic renal cell carcinoma, and Cervical cancer


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Amgen Inc.

Nerlynx

Neratinib Maleate Tablets

Puma Biotechnology, Inc.

Indicated for the extended adjuvant treatment of adult

patients with early stage HER2-overexpressed/amplified

breast cancer, to follow adjuvant trastuzumab-based

therapy

Ocrevus

Ocrelizumab Intravenous

Injection

Genentech, Inc.

Treatment of patients with relapsing or primary

progressive forms of multiple sclerosis

Odactra

House Dust Mite Allergen

Extract Sublingual Tablets

Merck & Co., Inc.

Indicated as immunotherapy for house dust mite (HDM)-

induced allergic rhinitis, with or without conjunctivitis in

adults 18 through 65 years of age

Ogivri

Trastuzumab-dkst


Mylan

Treatment of HER2-overexpressing breast cancer and

treatment of HER2-overexpressing metastatic gastric or

gastroesophageal junction adenocarcinoma

Ozempic

Semaglutide Subcutaneous

Injection

Novo Nordisk Inc.

Adjunct to diet and exercise to improve glycemic control

in adults with type 2 diabetes mellitus

Parsabiv

Etelcalcetide Intravenous

Injection

KAI Pharmaceuticals, Inc.

Treatment of secondary hyperparathyroidism (HPT) in

adult patients with chronic kidney disease (CKD) on

hemodialysis.

Prevymis

Letermovir Tablets and

Injection

Merck & Co., Inc.

Prophylaxis of cytomegalovirus (CMV) infection and

disease in adult CMV-seropositive recipients [R+] of an

allogeneic hematopoietic stem cell transplant (HSCT).

Radicava

Edaravone Intravenous

Injection

MT Pharma America, Inc.

Treatment of amyotrophic lateral sclerosis (ALS)

Rebinyn

Factor IX, GlycoPEGylated


Novo Nordisk Inc.

Indicated for use in adults and children with hemophilia B

for on-demand treatment and control of bleeding episodes

or perioperative management of bleeding

Renflexis

Infliximab-adba Intravenous

Injection

Merck & Co., Inc

Treatment of Crohn’s Disease, Pediatric Crohn’s Disease,

Ulcerative Colitis, Rheumatoid Arthritis in combination

with methotrexate, Ankylosing Spondylitis, Psoriatic

Arthritis, and Plaque Psoriasis

Rhopressa

Netarsudil ophthalmic solution

Aerie Pharmaceuticals, Inc

Indicated for the reduction of elevated intraocular pressure

in patients with open-angle glaucoma or ocular

hypertension


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Rituxan Hycela

Rituximab / Hyaluronidase

Human Subcutaneous

Injection

Genentech, Inc

Treatment of adult patients with Follicular Lymphoma

(FL), Diffuse Large B-cell Lymphoma (DLBCL), and

Chronic Lymphocytic Leukemia (CLL)

Rydapt

Midostaurin Capsules


Corporation

Treatment of adult patients with newly diagnosed acute

myeloid leukemia (AML) that is FLT3 mutation positive as

detected by an FDA-approved test, in combination with

standard cytarabine and daunorubicin induction and

cytarabine consolidation

Segluromet

Ertugliflozin / Metformin

Hydrochloride Tablets

Merck & Co., Inc


in adults with type 2 diabetes mellitus who are not

adequately controlled on a regimen containing ertugliflozin

or metformin, or in patients who are already treated with

both ertugliflozin and metformin.

Shingrix

Zoster Vaccine Recombinant,

Adjuvanted Intramuscular

Injection

GlaxoSmithKline

Prevention of herpes zoster (shingles) in adults aged 50

years and older.

Siliq

Brodalumab Subcutaneous

Injection

Valeant Pharmaceuticals North

America LLC

Treatment of moderate to severe plaque psoriasis in adult

patients who are candidates for systemic therapy or

phototherapy and have failed to respond or have lost

response to other systemic therapies.

Solosec

Secnidazole Oral Granules

Symbiomix Therapeutics LLC

Treatment of bacterial vaginosis in adult women.

Steglatro

Ertugliflozin Tablets

Merck & Co., Inc


in adults with type 2 diabetes mellitus

Steglujan

Ertugliflozin / Sitagliptin

Tablets

Merck & Co., Inc


in adults with type 2 diabetes mellitus when treatment with

both ertugliflozin and sitagliptin is appropriate.

Symproic

Naldemedine Tosylate Tablets

Shionogi Inc.

Treatment of opioid-induced constipation

Tremfya

Guselkumab Subcutaneous

Injection

Janssen Biotech, Inc

Treatment of adult patients with moderate-to-severe plaque

psoriasis who are candidates for systemic therapy or

phototherapy.

Trulance

Plecanatide Tablets

Synergy Pharmaceuticals Inc.

Treatment of chronic idiopathic constipation


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Tymlos

Abaloparatide Subcutaneous

Injection

Radius Health, Inc.

Treatment of postmenopausal women with osteoporosis at

high risk for fracture.

Vabomere

Meropenem and Vaborbactam


Treatment of complicated urinary tract infections including

pyelonephritis.

Verzenio

Abemaciclib Tablets

Lilly USA, LLC

In combination with fulvestrant for the treatment of women

with hormone receptor (HR)-positive, human epidermal

growth factor receptor 2 (HER2)-negative advanced or

metastatic breast cancer with disease progression following

endocrine therapy and as monotherapy for the treatment of

adult patients with HR positive, HER2-negative advanced

or metastatic breast cancer with disease progression

following endocrine therapy and prior chemotherapy in the

metastatic setting

Vosevi

Sofosbuvir, Velpatasvir, and

Voxilaprevir tablets

Gilead Sciences, Inc.

Treatment of adult patients with chronic HCV infection

without cirrhosis or with compensated cirrhosis (Child-

Pugh A) who have genotype 1, 2, 3, 4, 5, or 6 infection and

have previously been treated with an HCV regimen

containing an NS5A inhibitor or genotype 1a or 3 infection

and have previously been treated with an HCV regimen

containing sofosbuvir without an NS5A inhibitor.

Vyzulta Latanoprostene

Bunod Ophthalmic Solution

Bausch & Lomb

Reduction of intraocular pressure in patients with open-

angle glaucoma or ocular hypertension

Xadago

Safinamide Mesylate Tablets

US WorldMeds, LLC

Adjunctive treatment to levodopa/carbidopa in patients

with Parkinson’s disease experiencing “off” episodes

Xepi

Ozenoxacin Cream

Medimetriks Pharmaceuticals,

Inc

Topical treatment of impetigo due to Staphylococcus

aureus or Streptococcus pyogenes in adult and pediatric

patients 2 months of age and older

Xermelo

Telotristat Etiprate Tablets

Lexicon Pharmaceuticals, Inc.

Treatment of carcinoid syndrome diarrhea in combination

with somatostatin analog (SSA) therapy in adults

inadequately controlled by SSA therapy

Yescarta

Axicabtagene Ciloleucel


Kite Pharma, Inc

Treatment of adult patients with relapsed or refractory

large B-cell lymphoma after two or more lines of systemic

therapy, including diffuse large B-cell lymphoma

(DLBCL) not otherwise specified, primary mediastinal

large B-cell lymphoma, high grade B-cell lymphoma, and

DLBCL arising from follicular lymphoma

Zejula

Niraparib Tosylate Capsules

Tesaro, Inc.

Maintenance treatment of adult patients with recurrent

epithelial ovarian, fallopian tube, or primary peritoneal

cancer who are in a complete or partial response to

platinum-based chemotherapy


new drugs of … new drugs of 2017with table... · astrazeneca pharmaceuticals lp add-on...

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