FDA clears reformulated ranitidine for US return

The American medicines regulator has approved a reformulated version of ranitidine from USA-based VKT Pharma, restoring the acid-reducing drug to the market after a five-year gap. The green light covers 150mg and 300mg tablets and follows a remediation effort to eliminate NDMA impurity risks during storage.

The new product is said to offer the same therapeutic effect as the discontinued version, with updated labeling to guide safer handling. Patients are advised to keep tablets in the original bottle, protect them from moisture, and discard any unused supply after 90 days or by the listed expiry. Only one bottle should be opened at a time, with the desiccant kept in place.

The approval is expected to broaden access for patients who rely on H2 blockers, though the regulator recommends discussing any switch from alternative therapies with a healthcare professional.