FDA Approves Takeda's Dexilant SoluTab

Takeda Pharmaceuticals has announced that the United States (U.S.) Food and Drug Administration (FDA) approved Dexilant SoluTab delayed-release orally disintegrating tablets, a new formulation of dexlansoprazole that can be taken by allowing the tablet to melt in the patient's mouth. Dexilant SoluTab is a proton pump inhibitor (PPI) indicated for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) and the maintenance of healed erosive esophagitis (EE) and relief of heartburn in adults 18 years and older. Dexilant SoluTab is a PPI with dual delayed release (DDR) technology that is designed to provide two separate releases of medication.

"Our more than 20 years of leadership in gastroenterology has allowed us to provide another option that offers relief from heartburn associated with GERD in an orally disintegrating tablet," explained Thomas Gibbs, Senior Vice President, General Medicines, Takeda. "This new formulation expands the Dexilant Family and offers appropriate patients with GERD, who may struggle with swallowing capsules, a melt in your mouth alternative."  

In addition to Dexilant SoluTab, Dexilant is also available as a capsule. The capsule is indicated for heartburn associated with symptomatic non-erosive gastroesophageal reflux disease, the healing of erosive esophagitis (EE) and the maintenance of healed EE in adults. Since being approved by the FDA, Dexilant capsules have been available for nearly 7 years with over 25 million prescriptions filled.


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