FDA approves generic pediatric antibiotic
The Food and Drug Administration gave the okay to Ranbaxy Laboratories for its pediatric formulation of the generic antibiotic cefuroxime axetil.
The Food and Drug Administration gave the okay to Ranbaxy Laboratories for its pediatric formulation of the generic antibiotic cefuroxime axetil.
The drug, which is also sold as GlaxoSmithKline's Ceftin, is indicated for treatment of mild to moderate pharyngitis/tonsillitis, acute bacterial otitis media, and impetigo in patients 3 months to 12 years old. Two dose sizes have been approved, 125 mg/5 ml and 250 mg/5 ml.
Dupilumab (Dupixent) becomes first FDA-approved drug for adolescent CRSwNP
September 13th 2024The landmark indication is supported by a couple of pivotal trials assessing dupilumab for patients with chronic rhinosinusitis with nasal polyps, as well as a pediatric severe asthma trial assessing the biologic.
