FDA Roundup: Agency Highlights from October 2024
Drug Topics November 1, 2024
Check out these important FDA updates from the month of October 2024.
FDA Approves Abuse-Deterrent 10 mg Oxycodone Hydrochloride for Severe Pain
The FDA approved oxycodone hydrochloride (Roxybond) immediate-release (IR) CII 10 mg tablets for the management of severe pain that requires opioid analgesic treatment and for which alternative treatments are inadequate.
FDA Approves Sulopenem Etzadroxil and Probenecid for Uncomplicated UTIs
The FDA approved Iterum Therapeutics’ sulopenem etzadroxil and probenecid (Orlynvah) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by Escherichia coli, Klebsiella pneuomoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options.
FDA Approves Abrysvo for Adults 18-59 at Increased Risk for RSV
Pfizer’s respiratory syncytial virus (RSV) vaccine Abrysvo...