CHPA praises FDA committees’ decision to mandate weight-based dosing of APAP for children
SILVER SPRING, Md. — Two Food and Drug Administration advisory committees on Wednesday unanimously voted in favor of mandating weight-based dosing for children between the ages of 2 and 12 years who are being administered acetaminophen.
The joint committees — including both the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee — also supported a new label indication of fever for APAP for use in children between the ages of 6 months and 2 years. The committees did not support, however, an indication in labeling for children between ages 6 months to 2 years for pain relief. This indication currently is included for children older than 2 years.
"The manufacturers of pediatric acetaminophen products support the FDA advisory committee’s recommendations to give parents and caregivers more accurate and detailed dosing information where it is needed — directly on the Drug Facts label," stated Scott Melville, president and CEO of the Consumer Healthcare Products Association.
The CHPA also had supported a new indication for acetaminophen as a pain reliever in children under the age of 2 years, noting that pediatricians today recommend acetaminophen as a mainstay for the treatment of pain, including pain associated with ear infections, sore throat, teething and minor conditions. The advisory committees, many of whom are pediatricians, suggested that physicians can continue to recommend these medicines for pain relief in infants.
Ford developing health care in the dashboard
DEARBORN, Mich. — Ford Motor on Wednesday announced its research partnership with WellDoc — a healthcare company that develops technology solutions to improve chronic disease management outcomes and reduce healthcare costs — around integrating WellDoc services into Ford vehicles through the automaker’s SYNC voice-activated in-car connectivity system.
That SYNC system also will enable access to SDI’s Pollen.com Allergy Alert application, Ford announced Wednesday.
“The car has rapidly evolved into a mobile office and entertainment center for many Americans,” stated Venkatesh Prasad, group and technical leader of the Infotronics research and innovation team at Ford Motor. “Our goal is to further innovate the automotive space by incorporating health-and-wellness services into the car, thereby making them convenient and easily accessible to our customers — all while keeping their safety in mind. Delivering real-time, in-vehicle health management services is a revolutionary concept that we are proud to spearhead with WellDoc, a pioneer in the mobile health space.”
The research project between WellDoc and Ford demonstrates how adults with Type 2 diabetes can manage their disease using the WellDoc DiabetesManager System through SYNC. People with diabetes can enter their data, such as medications, exercise and diet information, through speech-to-text interaction while in their Ford vehicle. Patients who utilize the DiabetesManager System benefit from consistent interaction across their cell phone, computer and now their vehicle. The WellDoc software-based system also will allow healthcare providers to access their WellDoc clinical decision support records while they’re in the office, on their mobile device or in their Ford vehicle.
WellDoc’s DiabetesManager, which has been cleared by the Food and Drug Administration, provides automated, real-time clinical and behavioral coaching based on patient data. The software-based system supports adult Type 2 diabetes patients and enables their healthcare providers to configure specific parameters and extend their care beyond traditional office visits by utilizing mobile phones, the Internet and soon automobiles.
According to the U.S. Department of Transportation, Americans spend more than 500 million “commuter hours” per week in their automobiles, making it difficult to follow a daily health routine. By transforming the car into an access point that delivers health management content to patients in a safe, targeted and supportive manner, WellDoc and Ford are now enabling patients to maintain their daily routines even on the road.
Regarding the partnership with Pollen.com, developers enabled the Allergy Alert app for the iPhone to communicate via Ford’s SYNC using AppLink technology, giving users voice-controlled access to location-based forecasts for four different conditions: allergy (pollen), asthma, cold and cough, and ultraviolet sensitivity.
Pollen.com’s Allergy Alert app for the iPhone, which was launched in second quarter 2009, had more than 1 million users in 2010 with more than 80,000 downloads, putting it in the top 100 healthcare apps on iTunes. SDI expects the Allergy Alert SYNC app to be production-ready in third quarter 2011.
Perrigo receives final approval for generic Zantac 150
ALLEGAN, Mich. — Perrigo on Monday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter ranitidine 150 (regular and cool mint), a generic version of Zantac 150.
Zantac 150 has annual sales of approximately $110 million, as measured by SymphonyIRI Group, Perrigo reported.
"This approval is the first from our Allegan, Mich., facility since the company returned to acceptable regulatory status. It is another example of Perrigo’s commitment to bring new products to market,” Perrigo chairman and CEO Joseph Papa said.