FDA raises questions about Schering-Plough’s application for Zegerid
SAN DIEGO Santarus on Tuesday announced that Schering-Plough HealthCare Products recently received a Complete Response Letter from the Food and Drug Administration with questions on the proposed switch of Santarus’ prescription proton-pump inhibitor Zegerid.
Santarus is in regular communication with Schering-Plough, the specialty pharmaceutical company said, adding that Schering-Plough intends to continue to work closely with the FDA on a confidential basis to expeditiously address these questions and secure approval of OTC Zegerid.
The NDA for OTC Zegerid was submitted by Schering-Plough in March 2008. Schering-Plough licensed the OTC rights of Zegerid from Santarus in 2006.
Panasonic to enter hearing aid biz
SAN DIEGO Panasonic on Monday announced that it will enter the hearing care business in the U.S. market.
“As a leader in audio and video products for more than three quarters of a century, and a long history in hearing products in the Japanese market, Panasonic is well positioned to participate in the convergence of audio products and hearing aids,” stated Yoshi Yuasa, corporate SVP Panasonic Corporation of North America. “We believe that Panasonic hearing instruments have the potential to help audiologists provide more desirable solutions to their patients while helping to build Panasonic’s reputation for other types of healthcare solutions as well.”
Alaven launches Bifera iron supplement
Atlanta Alaven Consumer Healthcare on Monday launched its Bifera iron supplement, in preparation for the ECRM Vitamin, Diet and Sports Nutrition conference being held here Jan. 20 through Jan. 23.
Unique to the iron supplement category, Bifera offers both heme (protein-based iron) and non-heme iron (plant-based iron). Unlike other iron supplements available over-the-counter, Bifera provides two types of iron in one small pill for maximum absorption with virtually no gastrointestinal side effects. “Bifera can be taken on an empty stomach, with other multi-vitamin supplements and, unlike other over-the-counter iron supplements, Bifera can be taken with acid reduction medications,” stated Autumn Akin, Bifera product manager.Bifera is similar to Alaven’s current prescription prenatal supplement PreferaOB, which contains both heme and non-heme iron. Bifera is recommended for adults already taking supplemental iron, women of childbearing age, pregnant women, people who are anemic, and men and women who simply need more iron in their diet and the energy it provides.According to Curt Behrens, president of P2B, a retail sales and marketing company, Bifera is a significant advance among iron supplements. “This new iron technology will help millions of consumers and energize a sleepy category for retailers,” said Behrens. “Bifera’s new entrance into the iron category will appeal to dieticians, repeat buyers and lapsed iron users who are looking for reduced side effects and enhanced energy, all of which encourages patient compliance and repeat customers.”