FDA Approves Reformulated Ranitidine
November 25, 2025
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2 min
The FDA has approved VKT Pharma’s reformulated ranitidine in 150 mg and 300 mg doses, marking its return to the U.S. after a 5-year hiatus. This reformulation addresses past safety concerns regarding N-nitrosodimethylamine due to enhanced manufacturing processes. The drug maintains its therapeutic effects, supporting patients who previously depended on it for acid-related conditions. It is crucial for patients using other treatments to seek advice from their healthcare providers before transitioning to this version.
1. FDA approves reformulated ranitidine by VKT Pharma. 2. Available in 150 mg and 300 mg strengths. 3. Addresses previous safety concerns regarding N-nitrosodimethylamine. 4. Maintains therapeutic effectiveness for acid-related conditions. 5. Patients should consult healthcare providers before switching from other medications. 6. Store tablets in the original container with desiccant. 7. Discard unused tablets after three months or by expiration date. 8. Only open one bottle at a time to prevent moisture exposure.
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