Tag: H2 receptor antagonist news
-
FDA Approves Reformulated Ranitidine Following Comprehensive Safety Review
The U.S. Food and Drug Administration (FDA) has approved a reformulated ranitidine tablet after a comprehensive safety review addressing prior concerns about N‑nitrosodimethylamine (NDMA) impurity formation; the approval includes updated storage and handling requirements to mitigate impurity risk and preserve product stability. Background and regulatory context Ranitidine, an H2‑receptor antagonist widely used for gastroesophageal reflux…