FDA Information
Ranitidine has been approved by the Food and Drug Administration.
Ranitidine was first developed by Glaxo (now GlaxoSmithKline) in an effort to match the success of Smith, Kline & French (also now GlaxoSmithKline) with the first histamine H2-receptor antagonist cimetidine. Ranitidine was the result of a rational drug-design process utilising the, by then, fairly refined model of the histamine H2-receptor and quantitative structure-activity relationships.
Glaxo refined the model further by replacing the imidazole-ring of cimetidine with a furan-ring with a nitrogen-containing substituent, and in doing so developed ranitidine. Ranitidine was found to have a far-improved tolerability profile (i.e. fewer adverse drug reactions), longer-lasting action, and ten times the activity of cimetidine.
Ranitidine was introduced in 1981 and was the world's biggest-selling prescription drug by 1988. It has since largely been superseded by the even more effective proton pump inhibitors, with omeprazole becoming the biggest-selling drug for many years.
In US, GlaxoSmithKline received US FDA approval for Ranitidine 75 mg, the OTC version of the anti-ulcer drug.
Why is this medication prescribed?
Dosage and using this medicine
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What side effects can this medication cause?