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FDA Approves Reformulated Antacid 5 Years After It Was Pulled From Shelves
The FDA approved ranitidine with new manufacturing and storage guidelines to prevent NDMA impurity formation, enabling its return after nearly five years off U.S. shelves.
- On Monday, the U.S. Food and Drug Administration approved a reformulated ranitidine, allowing Zantac to return to U.S. shelves for the first time since its April 2020 removal.
- The April 2020 market withdrawal followed concerns over NDMA, which Valisure detected, prompting generic ranitidine manufacturers to halt distribution over contamination fears.
- Federal regulators announced approval of 150-mg and 300-mg ranitidine tablets after extensive safety testing, with updated labeling requiring storage in the original bottle with desiccant and discard after 90 days.
- The FDA advised patients and clinicians to discuss options before switching, as the reformulated ranitidine restores an H2 receptor antagonists choice for GERD and peptic ulcers with the same therapeutic effect.
- Scientific findings have varied, with a 2016 retracted study and later FDA and large 2023 studies finding no clear cancer risk, while the FDA says reformulation targets N‑Nitrosodimethylamine and adds risk mitigation measures.
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Total News Sources17
Leaning Left1Leaning Right0Center14Last UpdatedBias Distribution93% Center
Bias Distribution
- 93% of the sources are Center
93% Center
C 93%
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