Takeda announced that the Food and Drug Administration (FDA) has approved Dexilant (dexlansoprazole) delayed-release capsules and Dexilant SoluTab delayed-release orally-disintegrating tablets for patients aged 12–17 years with gastroesophageal reflux disease (GERD).
Dexilant, a proton pump inhibitor (PPI), is indicated for the treatment of heartburn associated with symptomatic non-erosive GERD and the maintenance of healed EE and relief of heartburn. Dexilant capsules are also approved for the healing of all grades of erosive esophagitis (EE). The expanded use of Dexilant in patients aged 12–17 years is supported by data from adequate and well-controlled studies of Dexilant capsules in adults, including additional safety, efficacy, and pharmacokinetic data in pediatric patients aged 12–17 years.
Dexilant works by suppressing gastric acid secretion through specific inhibition of the (H+, K+ )-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (-proton) pump within the parietal cell, dexlansoprazole has been characterized as a gastric proton-pump inhibitor, in that it blocks the final step of acid production.
Dexilant is available as 30mg and 60mg strength delayed-release capsules. Dexilant SoluTab is available as 30mg delayed-release orally-disintegrating tablets.
For more information call (877) 825-3327 or visit Dexilant.com.