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January 27, 2016

FDA approves Takeda’s Dexilant SoluTab to treat gastroesophageal reflux disease

The US Food and Drug Administration (FDA) has granted approval for Takeda Pharmaceuticals' Dexilant SoluTab delayed-release orally disintegrating tablets to treat adults with heartburn associated with Gastroesophageal Reflux Disease (GERD), a chronic condition called acid reflux disease.

The US Food and Drug Administration (FDA) has granted approval for Takeda Pharmaceuticals’ Dexilant SoluTab delayed-release orally disintegrating tablets to treat adults with heartburn associated with Gastroesophageal Reflux Disease (GERD), a chronic condition called acid reflux disease.

The disease can occur when the valve at the lower end of the esophagus, called the lower esophageal sphincter (LES), does not work properly.

Dexilant SoluTab, a proton pump inhibitor (PPI), is also indicated for the maintenance of healed erosive esophagitis (EE) and relief of heartburn in adults 18 years and older.

The drug is a new formulation of dexlansoprazole that can be taken by allowing the tablet to melt in the patient’s mouth.

"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."

It is a PPI with dual delayed release (DDR) technology that is designed to provide two separate releases of medication.

Takeda General Medicines senior vice-president Thomas Gibbs said: "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.

"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."

Apart from Dexilant SoluTab, Dexilant is also available as a capsule, which is indicated for heartburn associated with symptomatic non-erosive GERD, the healing of erosive esophagitis (EE) and the maintenance of healed EE in adults.

Since its approval from the FDA, Dexilant capsules have been available for nearly seven years, with more than 25 million prescriptions filled.

The company noted that two 30mg Dexilant SoluTab are not interchangeable with one 60mg Dexilant capsule.

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