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CENTER FOR DRUG EVALUATION AND RESEARCH
DIVISION of
DRUG INFORMATION
Your source for the latest drug information. Know the moment it happens.
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Correction: Yesterday, the U.S. Food and Drug Administration approved VKT Pharma's reformulated Ranitidine tablets in 150 mg and 300 mg strengths, marking the return of this important acid-reducing medication to the U.S. market after a five-year absence. |
FDA Approves Reformulated Ranitidine
Today, the U.S. Food and Drug Administration approved VKT Pharma's reformulated Ranitidine tablets in 150 mg and 300 mg strengths, marking the return of this important acid-reducing medication to the U.S. market after a five-year absence. The approval follows extensive safety testing and manufacturing improvements that address previous concerns about N-nitrosodimethylamine (NDMA) impurity formation during the product’s shelf-life.
Clinical Considerations: Healthcare providers and patients should be aware that the reformulated ranitidine maintains the same therapeutic effectiveness as previously approved products. Patients currently using alternative H2 blockers or proton pump inhibitors should consult their healthcare providers before switching medications. Approved products will include updated labeling with storage and handling instructions. Patients and healthcare providers should consider the new storage conditions for the safe and effective use of the product which include:
- Keep Ranitidine Tablets in the original container (bottle) and protect from moisture.
- After the first opening of the bottle, discard unused tablets after 3 months (90 days), or by the expiration date on the bottle, whichever is sooner.
- If more than one bottle is dispensed, open only one bottle at a time. Store additional bottles without opening until needed for dosing.
- At the time of dosing, remove one tablet from the bottle. Immediately close the bottle, secure the cap, and keep the bottle tightly closed.
- Keep the desiccant in the bottle.
This approval is expected to increase patient access to this important medication for patients who rely on it for various health conditions.
As always, patients should consult with their healthcare providers about the best treatment options for their individual needs.
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