Analytical Methods Used by the FDA for Drug Approvals in 2023

Utilizing robust and diverse analytical methods in 2023, the FDA ensured rigorous assessment of drug quality, safety, and efficacy in drug approval, providing reliable and effective treatments for patients, according to a study published in the Journal of Medical Pharmaceutical and Allied Sciences.

“In the year 2023, many drugs were approved by USFDA,” wrote corresponding author Pusuluri Siva Krishna, Department of Pharmaceutical Analysis, Vignan Pharmacy College in Vadlamudi, Gunter, Andhra Pradesh, India, and coauthors. “In order to develop a pharmaceutical product, new analytical methods have to be developed and validated.”

The analytical methods employed for the evaluation and quality control of FDA-approved drugs included high-performance liquid chromatography (HPLC), reverse phase high-performance liquid chromatography (RP-HPLC), Liquid Chromatography-Mass Spectrometry (LC-MS), Ultra-Performance Liquid Chromatography (UPLC), Ultra-high-performance liquid chromatography (UHPLC), Ultra-performance liquid chromatography-Mass Spectrometry and (UPLC-MS). These techniques can characterize, quantify, and assess pharmaceutical compounds for quality. These methods ensured reliable and effective treatments by facilitating rigorous drug quality, safety, and efficacy assessments for patients.

The drugs approved in 2023 using these methods include bexagliflozin (Sodium-glucose Cotransporter 2 Inhibitor (SGLT2)), daprodustat (hypoxia-inducible factor prolyl hydroxylase inhibitor), valmanasealfa-tycv (Recombinant human lysosomal alpha-mannosidase), rezafungin (echinocandin antifungal drug), sparsentan (dual endothelin and angiotensin II receptor antagonist), nirmatrelvir (anti-viral), ritonavir (protease inhibitors).

"This review will help in the future to develop the novel analytical methods for the selected approved drugs,” wrote the study authors. “Researchers will use this review to develop new methods for further studies on the selected drugs.”

Reference

Krishna PS, Eswarudu MM, Babu PS, et al. A review on analytical profile for newly FDA approved drugs in 2023. J Med Pharm Allied Sci. 2023:12(I4):5955-5961. doi:10.55522/jmpas.V12I4.5491