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.
Walgreens gets in the holiday spirit
Walgreens is promoting general merchandise and personal care products with its ‘Big Joy. Little Prices’ campaign.
The campaign is a way for Walgreens to drive sales by promoting everyday, front-end items ranging from shampoo to diapers.
Quigley to tap into OTC market
DOYLESTOWN, Pa. Quigley plans to focus on product developments in the over-the-counter arena, as opposed to developing prescription drug products, the company announced Thursday.
Though Quigley will continue to pursue the prescription-only development of QR333, a medicine for the symptomatic relief of diabetic peripheral neuropathy; QR440, a remedy for relief of inflammation and joint pain; and QR448, an anti-infective against infectious bronchitis in poultry.
Ted Karkus, Quigley chairman and CEO, suggested that Quigley would be placing the lion’s share of its investment behind brand development of Cold-Eeze. “We are particularly interested in leveraging our distribution network in mass, pharmacy and grocery retail by acquiring or developing additional personal care and OTC products,” he said. “We are aggressively searching for product acquisitions and researching line extensions of our Cold-Eeze and Kids-Eeze brands to accomplish these goals, diversify our product offerings and to set the stage for future growth of our company.”