Pharmaceutical Outsourcing Q3 2023 - 34

HORIZON LINES: A QUARTERLY REVIEW OF NDAs
HORIZON LINES
A Quarterly Review of New Drug
Applications - April-June, 2023
Neelam Sharma MS, Lavanya Kundurthy BE and
Hemant N. Joshi, Ph.D., MBA#
Tara Innovations LLC
#
hemantjoshi@tarainnovations.com;
www.tara-marketing.com
This quarterly review on New Drug Applications contains data for
applications approved during the second quarter of 2023, which
includes New Molecular Entities (NMEs) and new biologics. A total of
39 applications were approved by the FDA during these three months.
The NDAs approved during the second quarter of 2023 have
been divided into seven different dosage forms. Following are the
percentages of those dosage forms - Injection (48.7%), Tablets
(15.0%), Capsules (7.7%), Oral liquids - suspension/solution (7.7%),
Oral films (5.1%), Metered dose (5.1%) and other (10.1%, oral
granules, nasal spray, ophthalmic solution). Recently, there has been
more focus on injectable formulations. Following are the submission
classifications: BLA (17.5%), Type 1 (New molecular entity, 20.0%),
Type 3 (New dosage form, 20.0%), Type 4 (New combination, 10.0%),
and Type 5 (New formulation or manufacturer, 32.5%).
XACDURO® (sulbactam for injection; durlobactam for injection), copackaged
for intravenous use is a combination of sulbactam, a betalactam
antibacterial, and durlobactam, a beta-lactamase inhibitor,
approved in patients 18 years of age and older for the treatment of
hospital-acquired bacterial pneumonia and ventilator-associated
bacterial pneumonia (HABP/VABP) caused by susceptible isolates of
Acinetobacter baumannii-calcoaceticus complex (Acinetobacter).
QALSODY™ (tofersen) is indicated for the treatment of amyotrophic
lateral sclerosis (ALS) in adults who have a mutation in the superoxide
dismutase 1 (SOD1) gene. This indication is approved under
accelerated approval based on reduction in plasma neurofilament
light chain (NfL) observed in patients treated with QALSODY.
Fabry disease is a rare inherited disease caused by the deficiency
of an enzyme called alpha-galactosidase A that normally breaks
down a fatty substance called globotriaosylceramide (Gb3). It
can have varied symptoms such as pain in the hands, feet and
specific skin rashes. ELFABRIO is a hydrolytic lysosomal neutral
glycosphingolipid-specific enzyme indicated for the treatment of
adults with confirmed Fabry disease. The recommended dosage is 1
mg/kg every two weeks administered as an infusion.
MIEBO is a prescription eye drop used to treat the signs and symptoms
of dry eye disease. It works by preventing excessive tear evaporation.
It contains perfluorohexyloctane, a semifluorinated alkane that works
to stabilize the tear film on the surface of the eye, stopping the tears
from evaporating and preventing drying of the eyes.
LITFULO (ritlecitinib) is an oral, once-daily prescription treatment
for severe alopecia areata in adults and adolescents aged 12 and
older. Alopecia areata is an autoimmune disease characterized by
patchy hair loss, usually on the scalp but occasionally on the face
(eyebrows, eyelashes, beard) and other body areas. It is caused by
the body's immune system attacking healthy hair follicles, which
causes the hair to fall out.
Pharmaceutical Outsourcing | 34 | July/August/September 2023
http://www.tara-marketing.com
Pharmaceutical Outsourcing Q3 2023

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