Depomed sues FDA over drug for shingles-related pain
MENLO PARK, Calif. — A drug maker is suing the Food and Drug Administration to force the agency to give a special designation to one of its drugs.
Depomed announced that it had filed suit against the FDA in federal district court for the District of Columbia seeking an order that would require the agency to grant the drug Gralise (gabapentin) orphan drug exclusivity for the management of post-herpetic neuralgia. The disease, also known as PHN, is a condition causing prolonged pain in people who have had shingles, a complication of chickenpox.
The FDA granted Gralise orphan drug designation for management of PHN in November 2010 and approved the drug in January 2011, but it has not granted it orphan drug exclusivity. Under FDA regulations, orphan drug designation is given to drugs for diseases that affect fewer than 200,000 people in the United States, and drugs that receive the designation are entitled to seven years’ market exclusivity, as opposed to the five years given to other drugs.
SoloHealth Stations to roll out in Sam’s Club locations nationwide
ATLANTA — Sam’s Club has become the first warehouse club retailer to install SoloHealth’s comprehensive health-and-wellness screening kiosks, SoloHealth announced Wednesday.
SoloHealth said it will begin the rollout of its SoloHealth Station to more than 500 Sam’s Club locations nationwide. The kiosks, currently available in select U.S. retail locations, is expected to be in more than 2,500 retail locations by mid-2013.
"Providing innovative, preventative products and wellness services to our members is a major priority for Sam’s Club," Sam’s Club SVP health and wellness Jill Turner-Mitchael said. "As the first warehouse club retailer to install the SoloHealth Station for our members, Sam’s Club continues to deliver on that priority, providing support of preventive health to our communities and enabling our members to take charge of their health."
The SoloHealth Station provides health screenings for vision, blood pressure, weight, and body mass index, a symptom checker as well as an overall health assessment free of charge. The kiosk received the Food and Drug Administration’s stamp of approval this past June and also was recently honored with Intel’s coveted IT healthcare award, the "Intel Innovation Award."
"Sam’s Club shares our commitment of empowering consumers to take charge of their health," SoloHealth founder and CEO Bart Foster said. "We believe that awareness and education are keys to a healthy lifestyle, and we’re bringing a comprehensive self-service technology to neighborhood Sam’s Club locations nationwide. We are thrilled to announce our collaboration with Sam’s Club and look forward to continuing to grow the SoloHealth Station presence with our retailer partners."
Astellas applies for FDA approval of organ transplant drug
NORTHBROOK, Ill. — The U.S. subsidiary of Japanese drug maker Astellas is seeking approval from the Food and Drug Administration for a drug to prevent rejection of transplanted organs.
Astellas Pharma US said it applied with the FDA for approval of tacrolimus extended-release capsules to prevent rejection of transplanted kidneys in adults and transplanted livers in men. The drug was approved in Europe in 2007 under the name Advagraf and under the name Graceptor in Japan in 2008; the drug has been approved in 69 countries so far.
"There remains a large, unmet treatment need for transplant recipients who have a difficult time controlling their immunosuppression drug levels with existing products," Astellas global therapeutic area head for transplantation Roy First said. "Astellas believes tacrolimus extended-release capsules, given the efficacy, safety profile and unique dosing schedule, offer a potentially promising treatment option for recipients."