Santarus gets FDA approval for new PPI

SAN DIEGO Within a week of the switch approval of Zegerid OTC, specialty biopharmaceutical company Santarus, which licensed Zegerid OTC to Merck, gained Food and Drug Administration approval for a three-ingredient proton-pump inhibitor, the company announced Monday.

The new prescription-only formulation contains omeprazole, sodium bicarbonate and magnesium hydroxide in tablets of 40-mg and 20-mg dosage strengths of omeprazole.

The antacids sodium bicarbonate and magnesium hydroxide protect the omeprazole from acid degradation and facilitate its rapid absorption, Santarus stated.

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,” stated Gerald Proehl, Santarus president and CEO. “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.”

Santarus reported net product sales for Zegerid of $87 million for the nine months ended Sept. 30.