PharmaceuticalOutsourcingQ42020 - 55

HORIZON LINES: A QUARTERLY REVIEWSECTION
OF NDAs
TITLE

Approval
Date

Drug Name

Active Ingredients

Submission
Classification

Type of Dosage
Form/ Route

Company

Comments

07/02/2020

Tralement

Cupric Sulfate; Manganese
Sulfate; Selenious Acid;
Zinc Sulfate

Type 4 - New
Combination

Solution;
Intravenous

American Regent

The first and only FDA-approved multi-trace
element injection

07/02/2020

Bendamustine
Hydrochloride

Bendamustine Hydrochloride

Slayback Pharma
LLC

Approved tentatively under a 505(b)(2) application

Acacia

A very rapid onset/offset IV benzodiazepine
sedative for use during invasive medical procedures
lasting 30 minutes or less

07/02/2020

Byfavo

Type 5 - New
Formulation or Injectabl Injection
New Manufacturer

Remimazolam Besylate

Type 1 - New
Molecular Entity
and Type 4 - New
Combination

Powder;
Intravenous

Tablet, Extended
Release; Oral

ViiV Healthcare

Novel attachment inhibitor for the treatment of
HIV-1 infection indicated for use in combination
with other antiretroviral (ARV) therapies in heavily
treatment-experienced (HTE) adults

07/02/2020

Rukobi

Fostemsavir Tromethamine

Type 1 - New
Molecular Entity

07/06/2020

Qwo

Collagenase Clostridium
Histolyticum-Aaes

BLA

Injectable;
Injection

Endo Global
Aesthetics Ltd.

First FDA-approved injectable
treatment for cellulite.

07/06/2020

Hulio

Adalimumab-Fkjp

BLA

Injectable;
Injection

Mylan
Pharmaceutical
Inc.

A biosimilar to Humira.

Tablet; Oral

Otsuka

First and only orally administered hypomethylating
agent for the treatment for adults with
intermediate and high-risk myelodysplastic
syndromes (MDS)

07/07/2020

Inqovi

Cedazuridine; Decitabine

Type 1 - New
Molecular Entity

07/08/2020

Upneeq

Oxymetazoline Hydrochloride

_

Solution/Drops;
Ophthalmic

RVL
Pharmaceutical

Only FDA-approved medical treatment for ptosis.

07/18/2020

Carbon Dioxide, Usp

Carbon Dioide

_

Gas; Inhalation

Nexair LLC

Certification as a designated medical gas.

07/20/2020

Wynzora

Betamethasone Dipropionate;
Calcipotriene

Type 5 - New
Formulation or
New Manufacturer

Cream; Topical

MC2 Therapeutics

Novel topical treatment for plaque psoriasis

07/21/2020

Xywav

Calcium Oxybate; Magnesium
Oxybate; Potassium Oxybate;
Sodium Oxybate

_

Solution; Oral

Jazz

Oral Solution for Cataplexy or Excessive Daytime
Sleepiness Associated with Narcolepsy

07/23/2020

Breztri Aerosphere

Budesonide; Formoterol
Fumarate; Glycopyrrolate

_

Aerosol, Metered;
Inhalation

AstraZeneca AB

For the maintenance treatment of patients with
chronic obstructive pulmonary disease (COPD).

07/24/2020

Xeglyze

Abametapir

Type 1 - New
Molecular Entity

Lotion; Topical

Dr Reddys Labs SA

Lotion for the Treatment of Head Lice

07/30/2020

Cyclophosphamide

Cyclophosphamide

Type 5 - New
Formulation or
New Manufacturer

Solution;
Intravenous

Ingenus
Pharms LLC

Approved under 505(b)(2) submission.

07/31/2020

Monjuvi (TafasitamabCxix) For Injection

Tafasitamab-Cxix

BLA

Injectable;
Injection

Morphosys US Inc.

For the Treatment of Relapsed or Refractory Diffuse
Large B-cell Lymphoma (DLBCL)

08/03/2020

Vasopressin

Vasopressin

Type 5 - New
Formulation or
New Manufacturer

Solution;
Intravenous

American Regent

Approved under 505(b)(2) submission.

08/04/2020

Xtandi

Enzalutamide

Type 3 - New
Dosage Form

Tablet; Oral

Astellas

Only oral treatment approved by the FDA for 3
distinct types of advanced prostate cancer.

pharmoutsourcing.com |

55

| October/November/December 2020


http://www.pharmoutsourcing.com

PharmaceuticalOutsourcingQ42020

Table of Contents for the Digital Edition of PharmaceuticalOutsourcingQ42020

Editor's Message
Editorial Advisory Board
CN Perspectives
Social Media Connections
Insider Insight - Price
Insider Insight - Ventura
Contract Manufacturing
Supply Chain
Contract Manufacturing
Interview with Yourway
Supply Chain
Clinical Trials
Roundtable
Supply Chain
Analytical Testing
Supply Chain
Clinical Trials
Analytical Testing
Horizon Lines
Industry News
Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover1
PharmaceuticalOutsourcingQ42020 - Cover2
PharmaceuticalOutsourcingQ42020 - 1
PharmaceuticalOutsourcingQ42020 - Editor's Message
PharmaceuticalOutsourcingQ42020 - 3
PharmaceuticalOutsourcingQ42020 - 4
PharmaceuticalOutsourcingQ42020 - 5
PharmaceuticalOutsourcingQ42020 - Editorial Advisory Board
PharmaceuticalOutsourcingQ42020 - 7
PharmaceuticalOutsourcingQ42020 - CN Perspectives
PharmaceuticalOutsourcingQ42020 - Social Media Connections
PharmaceuticalOutsourcingQ42020 - Insider Insight - Price
PharmaceuticalOutsourcingQ42020 - 11
PharmaceuticalOutsourcingQ42020 - Insider Insight - Ventura
PharmaceuticalOutsourcingQ42020 - 13
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 15
PharmaceuticalOutsourcingQ42020 - 16
PharmaceuticalOutsourcingQ42020 - 17
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 19
PharmaceuticalOutsourcingQ42020 - Contract Manufacturing
PharmaceuticalOutsourcingQ42020 - 21
PharmaceuticalOutsourcingQ42020 - Interview with Yourway
PharmaceuticalOutsourcingQ42020 - 23
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 25
PharmaceuticalOutsourcingQ42020 - 26
PharmaceuticalOutsourcingQ42020 - 27
PharmaceuticalOutsourcingQ42020 - 28
PharmaceuticalOutsourcingQ42020 - 29
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 31
PharmaceuticalOutsourcingQ42020 - 32
PharmaceuticalOutsourcingQ42020 - Roundtable
PharmaceuticalOutsourcingQ42020 - 34
PharmaceuticalOutsourcingQ42020 - 35
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 37
PharmaceuticalOutsourcingQ42020 - 38
PharmaceuticalOutsourcingQ42020 - 39
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 41
PharmaceuticalOutsourcingQ42020 - 42
PharmaceuticalOutsourcingQ42020 - 43
PharmaceuticalOutsourcingQ42020 - Supply Chain
PharmaceuticalOutsourcingQ42020 - 45
PharmaceuticalOutsourcingQ42020 - 46
PharmaceuticalOutsourcingQ42020 - 47
PharmaceuticalOutsourcingQ42020 - Clinical Trials
PharmaceuticalOutsourcingQ42020 - 49
PharmaceuticalOutsourcingQ42020 - 50
PharmaceuticalOutsourcingQ42020 - Analytical Testing
PharmaceuticalOutsourcingQ42020 - 52
PharmaceuticalOutsourcingQ42020 - 53
PharmaceuticalOutsourcingQ42020 - Horizon Lines
PharmaceuticalOutsourcingQ42020 - 55
PharmaceuticalOutsourcingQ42020 - 56
PharmaceuticalOutsourcingQ42020 - 57
PharmaceuticalOutsourcingQ42020 - Industry News
PharmaceuticalOutsourcingQ42020 - 59
PharmaceuticalOutsourcingQ42020 - 60
PharmaceuticalOutsourcingQ42020 - 61
PharmaceuticalOutsourcingQ42020 - 62
PharmaceuticalOutsourcingQ42020 - 63
PharmaceuticalOutsourcingQ42020 - Advertiser's Index
PharmaceuticalOutsourcingQ42020 - Cover3
PharmaceuticalOutsourcingQ42020 - Cover4
https://www.nxtbook.com/comparenetworks/PharmaceuticalOutsourcing/po-q2-2021
https://www.nxtbook.com/comparenetworks/PharmaceuticalOutsourcing/PharmaceuticalOutsourcing2021CompanyFocus
https://www.nxtbook.com/comparenetworks/PharmaceuticalOutsourcing/PharmaceuticalOutsourcingQ42020
https://www.nxtbookmedia.com