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Dexilant SoluTab Approval History

  • FDA approved: Yes (First approved January 26th, 2016)
  • Brand name: Dexilant SoluTab
  • Generic name: dexlansoprazole
  • Dosage form: Delayed-Release Orally Disintegrating Tablets
  • Company: Takeda Pharmaceuticals U.S.A., Inc.
  • Treatment for: GERD

Dexilant SoluTab (dexlansoprazole) is a proton pump inhibitor (PPI) indicated for the treatment of patients with heartburn associated with gastroesophageal reflux disease (GERD).

Dexilant was first approved in capsule form in 2009. Dexilant SoluTab is a new formulation of dexlansoprazole that can be taken by allowing the tablet to melt in the mouth. The tablets may also be swallowed whole with water.

The recommended adult dosage for Dexilant SoluTab is one 30 mg tablet taken once daily at least 30 minutes before a meal. The tablets should be placed on the tongue, and allowed to disintegrate (melt). The remaining microgranules should be swallowed without water and should not be chewed.

The most commonly reported side effects include diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence. Patients should avoid alcohol during treatment with Dexilant SoluTab.

Development History and FDA Approval Process for Dexilant SoluTab

Jan 27, 2016Approval FDA Approves Takeda's Dexilant SoluTab (dexlansoprazole)

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