Kapidex (30mg and 60mg) is the first proton pump inhibitor (PPI) with a dual delayed release formulation designed to provide two separate releases of medication.
The approval was based on global studies conducted in 20 countries evaluating approximately 6,000 patients with erosive and non-erosive gastroesophageal reflux disease.
Alan MacKenzie, president and CEO of Takeda Pharmaceuticals North America, said: “Through the discovery, development and commercialization of new medicines, Takeda has been a leader in acid-related therapy for more than 15 years and is committed to bringing new therapies to market. Kapidex is a new, innovative treatment option in the well-established PPI market.”