The US Food and Drug Administration approved VKT Pharma's reformulated ranitidine in 150 mg and 300 mg strengths, returning the medication to the U.S. market after a 5-year absence. The reformulation followed extensive safety testing and manufacturing improvements intended to address previous concerns about N-nitrosodimethylamine (NDMA) impurity formation during the product's shelf-life.

According to the FDA, the medication maintains the same therapeutic effectiveness as previously approved ranitidine products. Patients currently using alternative histamine-2 receptor blockers or proton pump inhibitors are advised to consult their healthcare providers before switching to the reformulated ranitidine. The approved products include updated labeling with storage and handling instructions.

To ensure safe and effective use, patients are advised to follow specific storage requirements: keep tablets in the original container with the desiccant and protect them from moisture. After the first opening, unused tablets should be discarded after three months (90 days) or by the expiration date on the bottle, whichever is sooner. If multiple bottles are dispensed, only one should be opened at a time, with unopened bottles stored until needed. For each dose, patients should remove a single tablet, immediately close the bottle, secure the cap, and keep it tightly closed to limit moisture exposure.

The FDA noted that the 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.

Source: FDA