Pharmaceutical Outsourcing Q3 2023 - 35

HORIZON LINES: A QUARTERLY REVIEW OF NDAs
SECTION TITLE
Approval
Date
04/14/2023
04/21/2023
04/25/2023
04/26/2023
04/26/2023
04/27/2023
04/28/2023
04/28/2023
Drug Name
Rizafilm
Epinephrine
0.9% NaCl
Qalsody
Zejula
Trikafta
(Copackaged)
Abilify
Asimtufii
Uzedy
Liqrev
04/28/2023 Dolutegravir
04/28/2023
05/01/2023
05/04/2023
Symbicort
Aerosphere
Lumryz
Motpoly Xr
05/05/2023 Mydcombi
05/08/2023
05/09/2023
05/09/2023
05/11/2023
05/12/2023
05/18/2023
05/19/2023
05/22/2023
05/22/2023
Cefazolin
Sodium
Zolpidem
Tartrate
Elfabrio
Paclitaxel
Veozah
Miebo
Epkinly
Active Ingredients
Rizatriptan Benzoate
Epinephrine
Tofersen
Niraparib Tosylate
Elexacaftor, Ivacaftor,
Tezacaftor; Ivacaftor
Aripiprazole
Risperidone
Sildenafil Citrate
Dolutegravir
Budesonide;
Formoterol Fumarate
Sodium Oxybate
Lacosamide
Phenylephrine HCl;
Tropicamide
Cefazolin Sodium
Zolpidem Tartrate
Pegunigalsidase
Alfa-Iwxj
Paclitaxel
Fezolinetant
Perfluorohexyloctane
Epcoritamab-Bysp
Pemetrexed Pemetrexed Disodium
Nalmefene
Opvee
Hydrochloride
Type 3
Spray; Nasal
Indivior
Submission
Class. *
Type 3
Type 5
Type 1
Type 3
Type 3
Type 3
Type 5
Type 5
Type 5
Type 4
Type 5
Type 3
Type 5
Type 5
Type 3
BLA
Type 5
Type 1
Type 1
BLA
Type 5
Dosage Form
Film; Oral
Solution; I.V.
Solution; Intrathecal
Tablet; Oral
Granules; Oral
Suspension, ER, IM
Suspension, ER,
Subcutaneous
Suspension; Oral
Film; Oral
Aerosol, Metered Inhaler
For Suspension, ER, Oral
Capsule ER Oral
Spray, Metered;
Ophthalmic
Powder; Intravenous
Capsule; Oral
Vial; Single-Use
Powder;Intravenous
Tablet; Oral
Solution/Drops;
Ophthalmic
Injectable;
Subcutaneous
Solution; IV
Shilpa
Company
Comments
Intelgenx Corp.
Par Sterile Products
Biogen
GlaxoSmithKline
Vertex
Pharmaceuticals
Otsuka
Teva
CMP Development
Laurus Generics
AstraZeneca
Avadel
Pharmaceuticals
Aucta Pharma
Eyenovia
HQ Specialty
Pharma
Almatica
Chiesi Farmaceutici
Spa
Teva
Pharmaceutical
Astellas
Bausch And Lomb
Genmab US
First oral thin film treatment for acute migraine.
To increase mean arterial blood pressure in
adult patients with hypotension.
First approved treatment for amyotrophic lateral sclerosis.
A once-daily oral PARP inhibitor for adults with ovarian cancer.
To treat cystic fibrosis in patients 2 years and above.
To treat adults' schizophrenia and as maintenance monotherapy
for bipolar disorder in adults.
Extended-release injectable suspension for the treatment of
schizophrenia in adults.
For the treatment of pulmonary arterial hypertension to improve
exercise ability.
To treat HIV infection in combination with other HIV medicines
in adults.
A medicine for the treatment of asthma and COPD.
For extended-release oral suspension is the first and only singledose
sodium oxybate for adults with narcolepsy.
To treat partial-onset seizures in patients weighing at least 50 kg.
For the dilation of pupils during diagnostic procedures.
Used to treat bacterial infections in many different parts of the body.
It is used for temporary sleep problems in adults.
Is a prescription infusion medicine used to treat adults with
confirmed Fabry disease.
It is a type of chemotherapy called a taxane.
First neurokinin 3 (nk3) receptor antagonist to treat hot flashes
from menopause.
The first and only treatment for DED (dry eye disease) that directly
targets tear evaporation.
Accelerated approval for relapsed or refractory diffuse
large b-cell lymphoma.
For the treatment of patients with nonsquamous
non-small cell lung cancer.
A new nasal spray to reverse fentanyl and other opioid overdoses.
pharmoutsourcing.com | 35 | July/August/September 2023
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Pharmaceutical Outsourcing Q3 2023

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