FDA declines to approve Contrave
SAN DIEGO — The Food and Drug Administration has turned down an application for an anti-obesity drug.
Orexigen Therapeutics and Takeda Pharmaceutical said Tuesday that the FDA had issued a complete response letter for their application for Contrave (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets.
The FDA issues a complete response letter when it has finished reviewing the regulatory application for a drug, but questions remain that preclude final approval. In this case, the agency had concerns about cardiovascular safety risks in patients using the drug over the long term. The FDA said the companies must conduct a trial of “sufficient size and duration” to show that the cardiovascular risks of the drug don’t outweigh its benefits.
Duracell program to donate batteries to equip volunteer firefighters
BETHEL, Conn. — Procter & Gamble’s Duracell brand, in partnership with the National Volunteer Fire Council, on Monday kicked off a national battery donation program. The Power Those Who Protect Us program is designed to help equip the more than 730,000 volunteer firefighters with supplies they need to help power such firefighting gear as flashlights, breathing apparatuses and emergency personnel locators.
“We’re inviting communities across the country to join us in helping power those who protect us: our local volunteer firefighters,” stated Volker Kuhn, general manager of North America for Duracell. “With state budgets continuing to tighten, we’ve heard from some of these men and women that they could use some assistance with [such] resources [as] batteries, and we want to help."
Campaign spokesman and retired NFL quarterback Kurt Warner will be championing the Power Those Who Protect Us program, the companies announced. As part of the campaign, Warner will serve at his local Phoenix-area volunteer fire department, the Wickenburg Fire Department, for a day doing such firefighter training as live fire and rescue exercises and testing equipment.
P&G and the NVFC created the Power Those Who Protect Us program to raise awareness for the needs of these volunteers who donate their personal time and income to protect the community, the companies stated. With the help of consumers, the program goal is to provide 10 million batteries to the 23,000 volunteer fire departments in the United States.
According to a survey conducted on behalf of Duracell, 64% of volunteer firefighters surveyed reported that their department is not sufficiently funded to sustain all areas of operations. As many as 86% of volunteer firefighters reported that they or their families invested their own money in purchasing supplies and/or equipment for their department, with most of them (73%) investing up to $500 per year.
Consumers can participate in the Power Those Who Protect Us program by purchasing specially marked Duracell CopperTop battery packs at retailers nationwide beginning Jan. 31. For every specially marked Duracell CopperTop 10- and 20-pack of AA or AAA batteries purchased, Duracell will donate one or two batteries, respectively. Every department will receive a sizable battery donation, in some cases the equivalent of a year’s supply, depending on department size. Consumers can help increase the donation to their local volunteer departments further by directing their battery donation by zip code at Duracell.com/Protect or by visiting Facebook.com/Duracell and clicking on the program tab.
"Volunteer firefighters use batteries for a wide variety of crucial devices, such as personal alert systems, personnel location equipment, communication devices and flashlights," stated Philip Stittleburg, chairman of NVFC. "Funds are tight, so offsetting annual battery purchases provides local volunteer fire departments with genuine value, enabling them to reallocate resources to support the other areas of operation."
Stater Bros. celebrates diamond anniversary
SAN BERNARDINO, Calif. — A regional supermarket chain is celebrating 75 years of service.
Stater Bros. on Monday marked its diamond anniversary and announced that the chain will celebrate with various celebratory events and promotions, including teaming up with its supplier community and offering savings on items in its stores throughout the year.
"Celebrating 75 years is an unbelievable accomplishment for any company," stated Jack Brown, Stater Bros. chairman and CEO. "This milestone is certainly a testament to the loyalty and dedication of all the past and present members of our Stater Bros. supermarket family; to our devoted customers, many of whom are fifth-generation Stater Bros. shoppers; and to the partnerships [that] have been established with our supplier friends."