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The FDA has approved Santarus’s New Drug Application (NDA) for immediate-release Omeprazole/sodium bicarbonate/ magnesium hydroxide tablets in 40mg and 20mg dosage strengths of Omeprazole. Santarus had submitted the NDA for the tablet product in January 2009.
Reportedly, the NDA for the prescription drug was approved for all indications of heartburn and other symptoms associated with gastroesophageal reflux disease, or GERD; however, the FDA has not yet approved a trade name for the new product.
Santarus has submitted an NDA supplement requesting approval of a proposed trade name that includes the Zegerid brand name and anticipates that the FDA is expected to complete its review of the NDA supplement within 180 days.
The company said that the new dual buffer tablet product is an immediate-release proton pump inhibitor (PPI) that combines Omeprazole with the antacids sodium bicarbonate and magnesium hydroxide. The antacids protect the Omeprazole from acid degradation and facilitate its rapid absorption.
Santarus also promotes Zegerid (omeprazole/sodium bicarbonate) capsules and powder for oral suspension to gastroenterologists and other selected physicians.
Omeprazole/sodium bicarbonate/magnesium hydroxide tablets are indicated for the treatment of heartburn and other symptoms associated with GERD, for the short-term treatment of erosive esophagitis diagnosed by endoscopy, for maintenance of healing of erosive esophagitis, and for short-term treatment of active benign gastric ulcer and active duodenal ulcer.
Gerald Proehl, president and CEO of Santarus, said: “We are pleased to receive FDA approval for our new immediate-release prescription tablet product and our current plans are to launch in 2010 following approval of our NDA supplement.
“With its dual buffering system and convenient tablet dosage form, we believe this new immediate-release Omeprazole product will be an attractive addition to our Zegerid family of prescription products for the treatment of GERD and certain other upper GI conditions.”