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.
Unilever recalls Slim-Fast RTD products
ENGLEWOOD CLIFFS, N.J. Unilever on Thursday announced a nationwide voluntary recall of all Slim-Fast ready-to-drink products in cans due to the possibility of contamination with Bacillus cereus, a microorganism that can cause diarrhea and possibly nausea and/or vomiting.
The probability of serious adverse health consequences is remote, the company noted.
The products are packaged in paperboard cartons and contain four, six or 12 steel cans that are 11 Fl. oz. (325 mL) each. Individual cans are also sold in certain retail outlets. The recall involves all Slim-Fast RTD products in cans, regardless of flavor, Best-By date, lot code or UPC number.
No other Slim-Fast products are affected by this recall.
The recall was initiated after the company conducted quality testing on Slim-Fast RTD products in cans. Out of an abundance of caution, the company is recalling all RTD products in cans that are currently in distribution centers, on-shelf or in back rooms in retail outlets or in consumers’ homes. The company is in the process of identifying and correcting the production issue, and will resume production and shipment of the product when the issue has been addressed and corrected.
CDC reports drop in flu-related activity
ATLANTA Influenza continued to drop for the week ended Nov. 28, the Centers for Disease Control and Prevention noted Friday, as the number of states reporting widespread influenza-like illnesses dropped to 25 from 32.
But illness rates are still above the norm — 3.7% of all patient visits reported through the U.S. Outpatient Influenza-like Illness Surveillance Network were due to influenza-like illness. This percentage is above the national baseline of 2.3%.