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FDA approves Dexilant SoluTab for GERD
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Takeda has announced that the FDA approved its Dexilant SoluTab delayed-release formulation of the proton pump inhibitor dexlansoprazole indicated for treating heartburn associated with GERD and maintaining healed erosive esophagitis in adults.
The new formulation is an orally disintegrating tablet that melts in a patient’s mouth, and its dual delayed release technology provides two separate releases of the medication, according to a press release.
“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,” Thomas Gibbs, senior vice president of general medicines at Takeda, said in the press release. “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.”
FDA-approved Dexilant capsules have been available for almost 7 years for the treatment of heartburn associated with symptomatic nonerosive GERD and for healing and maintaining healed erosive esophagitis in adults.
Two 30-mg Dexilant SoluTabs are not interchangeable with one 60-mg Dexilant capsule, according to the press release, and they may also be swallowed whole with water.