New Drug Approvals

JUNE 11, 2025

4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] 4] This came after the drug had been rejected by the Food and Drug Administration (FDA) three times over two decades due to insufficient evidence of effectiveness. [5] The FDA rejected approval for gepirone in 2002 and 2004. [5]

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FDA FDA Approval Treatment Clinical Trials 62

New Drug Approvals

APRIL 19, 2025

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 “Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. 32 (2): 828.

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The FDA maintains a webpage with the full rulemaking history for OTC nasal decongestant drug products.

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Advarra

DECEMBER 14, 2022

Effective as of 2007, Medicare has offered coverage for routine costs in clinical trials. FDA-approved IDE devices may be deemed qualifying under the Medicare Benefit Policy Manual, Chapter 14. Safety, quality of life, and pharmacokinetic (PK) responses are not considered to be therapeutic objectives.

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New Drug Approvals

APRIL 27, 2025

3] It was patented in 1966 and approved for medical use in 1974. [6] 6] It was first approved in the US in 2004, and an extended release version was brought to market in 2007. It became generic in the EU in 2009, and the first extended-release generic was approved in the US in 2012. billion in 2004. [23]

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FDA Approval FDA Pharmacokinetics Licensing 57

New Drug Approvals

MAY 22, 2025

4] The co-packaged combination sulbactam/durlobactam was approved for medical use in the United States in May 2023. [5] 7] References ^ Totir MA, Helfand MS, Carey MP, Sheri A, Buynak JD, Bonomo RA, Carey PR (August 2007). “Pharmacokinetics and Pharmacodynamics of -Lactamase Inhibitors” Pharmacotherapy. PMC 2596720.

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Codon

FEBRUARY 23, 2025

Zidovudine showed promise against multiple HIV strains in cultured cells, and the Food and Drug Administration (FDA) approved it for human studies within five months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates.

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