GSK Reports the US FDA’s sNDA Acceptance and Priority Review of Blujepa for Uncomplicated Urogenital Gonorrhoea

Shots:The US FDA has accepted sNDA & granted priority review to Blujepa (gepotidacin) for the treatment of pts (≥12yrs.; ≥45kg) with uncomplicated urogenital gonorrhoea (PDUFA: Dec 11, 2025); regulatory review is ongoing in the UK & AustraliasNDA was backed by P-III (EAGLE-1) trial assessing Blujepa (2 doses × 3000mg; PO) vs ceftriaxone (500mg; IM)…

ByRidhi RastogiAugust 11, 2025

INSIGHTS+

The US FDA New Drug Approvals in March 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of March 2025 The US FDA has approved a total of 2 new drug including 2 new molecular entities leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was GSK’s Blujepa securing approval for treating…

ByDipanshu DixitApril 15, 2025

NEWS

GSK Reports the US FDA’s Approval of Blujepa (Gepotidacin) to Treat Uncomplicated Urinary Tract Infections (uUTIs)

Shots:The US FDA has approved Blujepa to treat uUTIs in female adults (≥40kg) & adolescents (≥12yrs., ≥40kg) caused by E. coli, K. pneumoniae, C. freundii complex, S. saprophyticus & E. faecalis; commercially available in H2’25Approval was based on P-III (EAGLE-2, n=1531; EAGLE-3, n=1605) studies assessing gepotidacin (1500mg, PO, BID for 5 days) vs nitrofurantoin (100mg, PO, BID for 5 days)…

ByDipanshu DixitMarch 26, 2025

GSK Reports the US FDA’s sNDA Acceptance and Priority Review of Blujepa for Uncomplicated Urogenital Gonorrhoea

The US FDA New Drug Approvals in March 2025

GSK Reports the US FDA’s Approval of Blujepa (Gepotidacin) to Treat Uncomplicated Urinary Tract Infections (uUTIs)

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