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news.Santarus, a pharmaceutical company specializing in gastrointestinal treatments, has revealed that the FDA has accepted the filing of a new drug application for its Zegerid capsules.
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Santarus is seeking marketing approval of Zegerid capsules 20mg and 40mg, which according to the company is a proton pump inhibitor (PPI) in capsule formulation that treats symptoms associated with gastroesophageal reflux disease (GERD), erosive esophagitis, duodenal ulcers and gastric ulcers. Santarus claims that capsules are the most widely used dosage form within the PPI class of drugs.
“We believe that GERD patients may find our immediate-release capsules convenient for daily use and, subject to regulatory approval, commercialization of this formulation could broaden Zegerid usage,” said Gerald Proehl, president of Santarus.
The company is also planning to release three product formulations of immediate-release Zegerid, including powder for oral suspension, capsules and chewable tablets.
Santarus is currently promoting Zegerid Powder for Oral Suspension, a PPI product which provides 24-hour acid control with once daily dosing.
In connection with the filing of the Zegerid Capsules application, Santarus has informed the patent holders of Prilosec delayed-release omeprazole capsules that its Zegerid Capsules do not infringe the patents listed in the Orange Book for Prilosec.
Santarus expects the FDA will complete its review or otherwise respond to the application by February 26, 2006.