‘Comprehensive Review of Approved Biological Products by The U.S. FDA in 2023

Abstract

The United States Food and Drug Administration (US.FDA) approved numerous innovative pharmaceuticals in 2023. These pharmaceuticals have been subjected to a rigorous evaluation to guarantee their safety and efficacy, and they represent substantial improvements in the treatment of a variety of medical conditions. A diverse array of analytical techniques has been implemented to facilitate their development and subsequent quality control. The analytical methodologies utilized for the evaluation and quality control of FDA-approved drugs are the primary focus of this review. These methodologies comprise a variety of methods that facilitate the characterization, quantification, and quality assessment of pharmaceutical compounds. Frequently implemented chromatographic methods, including highperformance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry, are among the analytical techniques. Spectrometry (LC-MS), UltraPerformance Liquid Chromatography (UPLC), Ultra-high-performance liquid chromatography (UHPLC), and Ultraperformance liquid chromatography-Mass Spectrometry (UPLC-MS). The drugs that have been approved are bexagliflozin (Sodium-glucose cotransporter 2). Daprodustat (Hypoxia-inducible factor prolyl hydroxylase inhibitor), Valmanasealfa-tycv (Recombinant human lysosomal alphamannosidase), Rezafungin (Echinocandin antifungal drug), Sparsentan (Dual endothelin and angiotensin II receptor antagonist), and Nirmatrelvir (Antiviral), Ritonavir (Protease Inhibitors). In general, the FDA's approval of pharmaceuticals in 2023 was contingent upon the implementation of a variety of robust analytical methods. These methods enabled the comprehensive evaluation of drug quality, safety, and efficacy, thereby guaranteeing that patients receive reliable and effective treatment. The development and evaluation of innovative technologies will be further facilitated by the ongoing advancement of analytical techniques pharmaceuticals in the future.