FDA approves Santarus’ NDA for immediate-release prescription tablet product

Dec 5 2009

Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s New Drug Application (NDA) for immediate-release omeprazole/sodium bicarbonate/ magnesium hydroxide tablets in 40 mg and 20 mg dosage strengths of omeprazole. Santarus submitted the NDA for this tablet product in January 2009.

The NDA for the new prescription tablet product was approved for all indications the company was seeking, including for the treatment 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 will complete its review of this NDA supplement within 180 days.

“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,” said Gerald T. Proehl, president and chief executive officer. “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.”

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. Santarus reported net product sales for ZEGERID of $87 million for the nine months ended September 30, 2009.

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 (controlled studies do not extend beyond 12 months), and for short-term treatment of active benign gastric ulcer and active duodenal ulcer.