Top Ten US-FDA Approved Pharmacological Agents in 2023: A Year in Review
We come to the end of 2023. Here are top ten pharmacological
agents that received US-FDA approval throughout this year, across key therapy
areas:
1) Zilucoplan
Zilucoplan
is a complement inhibitor indicated for the treatment of generalized myasthenia
gravis in adult patients who are anti-acetylcholine receptor antibody
positive.
It
is available in the form of single-dose pre-filled syringe injections in dosage
strengths, 16.6 mg, 23 mg & 32.4 mg.
It is available under the brand name ZILBRYSQ, It is a product of the
UCB group of companies, Georgia, USA
2) Etrasimod
Etrasimod
is a sphingosine 1-phosphate receptor modulator indicated for the treatment of
moderately to severely active ulcerative colitis in adults. It is available in
the form of 2 mg tablets. It is available under the brand name, VELSIPITY. It
is a product of Pfizer Labs, a division of Pfizer, NYC, USA
3) Gepirone
Gepirone,
a plausible serotonergic modulator is indicated for the treatment of major
depressive disorders in adults. It is available in the form of extended-release
tablets of 18.2 mg, 36.3 mg, 54.5 mg, and 72.6 mg respectively. It is available
under the brand name EXXUA. It is a product of Fabre Kramer, headquartered in
Houston, Texas, USA
4) Motixafortide
Motixafortide
is a hematopoietic stem cell mobilizer, is indicated in combination with
filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood
for collection and subsequent autologous transplantation in patients with
multiple myeloma. It is available in injection form, 62 mg as a lypophilised
powder in a single-dose vial for reconstititution. It is available under the
brand name APHEXDA. It is a product of Bioline Rx, Waltham,
Massachusetts, USA.
5) Ritlecitinib
Ritlecitinib
is a kinase inhibitor indicated for the treatment of severe alopecia areata in
adults and adolescents 12 years and older. It is available in 50 mg capsules,
with once-daily dosing among eligible patients. It is available under the brand
name LITFULO. It is a product of Pfizer Inc., NYC, USA.
6) Sotagliflozin
Sotagliflozin
is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated to reduce the
risk of cardiovascular death, hospitalization for heart failure, and urgent
heart failure visits in adults with heart failure, or type 2 diabetes mellitus,
chronic kidney disease, and other cardiovascular risk factors. It is available
in the form of tablets of 200 mg and 400 mg.
It is available under the brand name INPEFA. It is a product of Lexicon,
based in Texas, USA
7) Sulbactam/Durlobactam
Injection
Sulbactam/Durlobactam is a
co-packaged product containing sulbactam, a beta-lactam antibacterial and beta-lactamase
inhibitor, and durlobactam, a beta-lactamase inhibitor, indicated in patients
18 years of age and older for the treatment of hospital-acquired bacterial
pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused Acinetobacter
baumannii-calcoaceticus complex.
It is an injection available as a co-packaged
kit containing the following two components as sterile powders for
reconstitution.
•
1 clear single-dose vial of sulbactam for injection 1 g and
•
2 amber single-dose vials of durlobactam for injection 0.5 g.
It is available under the brand name
XACDURO. It is a product of Entasis Therapeutics Inc, Waltham, Massachusetts,
USA.
8) Perflurohexyloctane
Perfluorohexyloctane ophthalmic
solution is a semifluorinated alkane indicated for the treatment of the signs
and symptoms of dry eye disease.
It
is available as a topical solution for ophthalmic use containing 100%
Perfluorohexyloctane. It is available under the brand name, MIEBO. It is the
product of Bausch & Lomb Inc., New Jersey, USA
9) Zavegepant
Zavegepant
is a Calcitonin gene-related peptide receptor antagonist indicated for the
acute treatment of migraine with or without aura in adults. It is available in
the form of 10 mg nasal spray formulation. It is available under the brand name
Zaxzpret. It is a product of Pfrizer, Inc., NYC, USA.
10) Bexagliflozin
Bexagliflozin is a sodium-glucose
co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise
to improve glycemic control in adults with type 2 diabetes mellitus. It is
available in the form of 20 mg tablets. It is available under the brand name,
BRENZAVVY. It is a product of Theracos Bio, LLC, Marlborough,
Massachusetts, United States.
