Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA077652 for Levofloxacin Oral Tablets
The FDA has approved ANDA077652 for levofloxacin tablets (250 mg, 500 mg, 750 mg) manufactured by Zydus Lifesciences and Viona Pharmaceuticals.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA206517 for Aztreonam Injectable Products
FDA has approved Hospira's aztreonam injectable (1 g and 2 g vials) for intramuscular and intravenous use under ANDA206517.
Regulatory Updates
Sep 2, 2026•1 min read
FDA approves five new products in June, spanning cell therapy to biosimilars
The FDA granted approvals for five products in June—including a cell therapy, rare‑disease drug, antibiotic, imaging contrast agent and a biosimilar—signaling trends in advanced biopharma.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves OFLOXACIN OTIC (ANDA 076527) Generic Ear Drops
The FDA approved Apotex's OFLOXACIN OTIC (0.3% otic solution) under ANDA 076527, with original approval on Sep 28, 2007 and a labeling supplement on Aug 6, 2008.
Regulatory Updates
Aug 27, 2026•1 min read
GSK and Spero Therapeutics Secure FDA Approval for Oral Carbapenem Utebzi for cUTI
GSK and Spero Therapeutics received FDA approval for Utebzi, the first oral carbapenem antibiotic for complex urinary tract infections, including pyelonephritis.
Regulatory Updates
Aug 24, 2026•1 min read
Spero Therapeutics and GSK Advance Utebzi Toward FDA Approval
Four years after a FDA rejection, Spero Therapeutics and GSK have moved their oral UTI drug Utebzi closer to approval.