Friday, Santarus, Inc. (SNTS), a biopharmaceutical company, reported that the U.S. Food and Drug Administration or FDA has approved the company's New Drug Application or NDA for immediate-release omeprazole/sodium bicarbonate/ magnesium hydroxide tablets in 40 mg and 20 mg dosage strengths of omeprazole.
The San Diego, California-based company said that 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.
"With its dual buffering system and convenient tablet dosage form, we believe this new immediate-release product will be an attractive addition to our Zegerid family of prescription products for the treatment of GERD and certain other upper GI conditions," said Gerald Proehl, president and CEO.
According to Santarus, the new dual buffer tablet product is an immediate-release proton pump inhibitor or 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.
However, the FDA has not yet approved a trade name for the new product. Santarus said that it 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.
Santarus also promotes Zegerid or 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.
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.
The company said that the most frequently reported adverse events with the tablets are headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence. The tablets contain 750 mg or 9 mEq of sodium bicarbonate, which is equivalent to 209 mg of Na+ and 343 mg or 12 mEq of magnesium hydroxide, which is equivalent to 143 mg of Mg2+.
SNTS closed Friday's trade on the Nasdaq at $4.98, up $0.02 or 0.40%. In the after hours the stock traded up $0.32 or 6.43%.
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