Pharmaceutical Outsourcing Q3 2023 - 36

HORIZON LINES: A QUARTERLY REVIEW OF NDAs
Approval Date
05/23/2023
05/23/2023
05/23/2023
05/25/2023
05/25/2023
05/26/2023
05/26/2023
05/30/2023
06/07/2023
06/15/2023
06/15/2023
06/16/2023
06/20/2023
06/23/2023
Drug Name
Brixadi
Xacduro (Copackaged)
Yuflyma
Posluman
Paxlovid (Copackaged)
Dolutegravir,
Emtricitabine and
Tenofovir Alafenamide
Inpefa
Vevye
Cyclophosphamiden
Suflave
Columvi
Lodoco
Vyvgart Hytrulo
Litfulo
Active Ingredients
Buprenorphine
Durlobactam Sodium;
Durlobactam Sodium;
Sulbactam Sodium
Adalimumab-Aaty
Flotufolastat F-18 Gallium
Nirmatrelvir; Ritonavir
Dolutegravir, Emtricitabine
and Tenofovir Alafenamide
Sotagliflozin
Cyclosporine
Cyclophosphamide
Polyethylene Glycol 3350;
MgSO4, KCl, NaCl, Na2SO4
Glofitamab-Gxbm
Colchicine
Efgartigimod Alfa And
Hyaluronidase-Qvfc
Ritlecitinib Tosylate
06/26/2023
06/27/2023
06/27/2023
Rystiggo
Cyclophosphamide
Ngenla
Rozanolixizumab-Noli
Submission
Class. *
Type 3
Type 1 and
Type 4
BLA
Type 1
Type 1
Type 4
Type 1
Type 5
Type 5
Type 4
BLA
Type 5
BLA
Type 1
BLA
Dosage Form
Solution, ER,
Subcutaneous
Powder; Intravenous
Injectable
Solution; I.V.
Tablet; Oral
Tablet; Oral
Tablet; Oral
Solution; Ophthalmic
Solution; I.V.
Solution; Oral
Injectable
Tablet; Oral
Injectable
Capsule; Oral
Injectable;
Subcutaneous
Cyclophosphamide
Somatrogon-Ghla
Type 5
BLA
Solution; I.V.
Injectable
Nevakar Injectables
Pfizer Ireland
Pharmaceuticals
Company
Comments
Braeburn
Entasis Therapeutics
Celltrion
Blue Earth
Pfizer
Aurobindo Pharma
USA
Lexicon
Pharmaceuticals
Novaliq
Dr. Reddy's
Braintree Labs
Genentech
Agepha Pharma
argenx
Pfizer
To treat moderate to severe
opioid use disorder (oud).
The first pathogen-targeted therapy approved
to treat hospital-acquired and ventilatorassociated
pneumonias caused by acinetobacter.
The first high-concentration and citrate-free
adalimumab biosimilar.
First radiohybrid psma-targeted pet imaging
agent for prostate cancer.
First oral antiviral for treatment of
covid-19 in adults.
For the treatment of HIV infection.
The first sglt1/sglt2 inhibitor to reduce risk of
heart failure.
Water free product to treat dry eye disease signs
and symptoms.
Ready-to-dilute multidose injection
in oncology therapy.
Low-volume bowel preparation drink.
Accelerated approval for selected relapsed or
refractory large b-cell lymphomas.
First anti-inflammatory atheroprotective
cardiovascular treatment.
First fda-approved subcutaneous (sc) injectable
for generalized myasthenia gravis (gmg).
The first and only treatment for severe alopecia
areata approved for patients as young as 12.
UCB
The only fda-approved treatment in adults for
both anti-achr and anti-musk antibody-positive
gmg (generalized myasthenia gravis).
Ready-to-dilute multidose injection
in oncology therapy.
A long-acting once-weekly treatment for
pediatric growth hormone deficiency.
BLA : Biologics License agreement, Type 1: New Molecular entity, Type 3: New dosage form, Type 4: New combination, Type 5 - New formulation or manufacturer.
Pharmaceutical Outsourcing | 36 | July/August/September 2023

Pharmaceutical Outsourcing Q3 2023

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