Topaz seeks FDA approval for head lice treatment
HORSHAM, Pa. — The Food and Drug Administration has accepted a regulatory approval application for a head lice treatment made by Topaz Pharmaceuticals, Topaz said Tuesday.
Topaz is seeking approval for ivermectin topical cream, for treating head lice in children and adults.
“This filing represents the transition of the company from the development phase as we are now preparing to commercialize our lead product candidate,” Topaz president and CEO Robert Radie said. “Current treatment options are limited by one or more of safety, efficacy and convenience issues. We believe there is an unmet need to provide a new option for the more than 6 million people, mostly school-aged children, who are impacted by lice each year in the United States.”
Take Care joins forces with Jacksonville, Fla., health system
JACKSONVILLE, Fla. — Take Care Health Systems and Memorial Health on Tuesday announced a new relationship that will increase opportunities for clinical collaboration and improve patient access to high-quality, convenient and affordable healthcare options in the greater Jacksonville region.
Through the enhanced relationship, Memorial Health-affiliated physician practices will share information on Take Care Clinics and other healthcare options when their locations are closed or they are unable to schedule an appointment within a patient’s desired time frame. Professionals at Memorial Health-affiliated practices will have access to information on Take Care Clinic locations, evening and weekend hours, and services available to patients and their families.
“The team at Memorial Health is committed to providing the Jacksonville community with healthcare services when and where they are needed,” said Wayne Winney, divisional VP with HCA physician services. “By partnering with Walgreens and Take Care Health [Systems] we’re facilitating patient access to a high-quality healthcare provider while ensuring continuity of care with the Memorial Health team. We believe that sharing information on Take Care Clinics can play a role in limiting unnecessary emergency room visits and improving the care experience for Memorial Health patients.”
Providers at Take Care Clinics will have information available to educate patients on Memorial Health services and will continue to provide information on a variety of local healthcare resources as appropriate. If a patient at a Take Care Clinic requires care that falls outside of the setting’s scope of service, dedicated systems between Take Care Health Systems and Memorial are in place to allow for rapid sharing of visit records with patient permission. Take Care Clinic professionals provide all patients with a copy of their visit record and will share records with other healthcare providers upon request.
Patients today increasingly are looking for affordable, accessible healthcare options. According to research published in the September 2010 issue of Health Affairs, between 13.7% and 27.1% of emergency department visits could take place at retail clinics or urgent care centers, with a potential cost savings of $4.4 billion annually. According to this research, retail clinics, such as Take Care Clinics at select Walgreens, have been shown to save patients $279 to $460 per visit, compared with emergency department costs.
Actavis granted final approval for generic Ambien CR
MORRISTOWN, N.J. — The Food and Drug Administration has given final approval to a generic drug for insomnia made by Actavis, the drug maker said Monday.
The FDA approved the company’s zolpidem tartrate extended-release tablets in the 12.5-mg strength. The drug, which is a Schedule IV controlled substance, is a generic version of Sanofi’s Ambien CR. Actavis was the first company to launch a generic version of the drug in the 6.25-mg strength in October 2010.
Zolpidem tartrate extended-release tablets had sales of about $793 million in the 12-month period ended in March, according to IMS Health.