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.