CHPA supports keeping OTC bronchodilators in the OTC Monograph
WASHINGTON — The Consumer Healthcare Products Association earlier this week voiced support for keeping over-the-counter bronchodilators in the OTC Monograph during a recent meeting of the Food and Drug Administration’s Nonprescription Drugs Advisory Committee.
During the meeting, the committee discussed whether bronchodilators administered by hand-held rubber bulb nebulizers for the temporary relief of mild symptoms of intermittent asthma (shortness of breath, tightness of chest and wheezing) should be removed from the monograph. Specific drugs discussed included epinephrine, epinephrine bitartrate and racepinephrine hydrochloride.
CHPA VP regulatory and scientific affairs Barbara Kochanowski spoke on behalf of CHPA, stating that there is no obvious reason to abandon the OTC Monograph as a regulatory path to market. She noted that the FDA has the ability to amend the monograph to ensure proper performance specifications, such as dosing.
Kochanowski also highlighted that more than 25 million Americans suffer from asthma, and under-use of asthma medicines, particularly among minorities, is an acknowledged challenge.
Perrigo acquires portfolio of Australian OTC products for $51 million
DUBLIN — Perrigo on Friday announced that it has acquired a basket of value-brand OTC products sold in Australia and New Zealand from Aspen Global for $51 million in cash.
The products are primarily sold through the mass retail channel and include the Herron range of analgesics, vitamins and supplements. This basket of products is expected to generate at least $20 million in annual revenue.
"The acquisition of OTC products in Australia enhances our position by broadening our product offering and increasing our relevance with the mass retail customers," stated Joseph Papa, Perrigo chairman, president and CEO. "This deal furthers our strategy to expand our Consumer Healthcare portfolio internationally, while making quality products more affordable for consumers and customers around the world."
Verizon’s Converged Health Management platform gains 510(k) clearance
NEW YORK — Verizon’s Converged Health Management, a remote patient-monitoring medical platform designed to help clinicians and patients manage patients’ health in between doctor visits, recently received Food and Drug Administration 510(k) clearance to run on the iOS mobile operating system, Verizon announced Tuesday.
Patients and clinicians now will be able to access Verizon’s solution on their iPhones and can use their iPads to access the Converged Health Management portal.
In addition, Converged Health Management added Telcare and Genesis blood glucose monitors to its line of biometric devices to its secure, device-agnostic platform. These join the list of other available biometric devices, including Ideal Life’s blood pressure cuff, glucose monitor model, pulse oximeter and weight scale.
The new enhancements give customers added choice to deliver and customize mobile health solutions to patients and employees. In fact, 59% of physicians who use mobile medical apps do so on a tablet device, and from within that group, most prefer the iPad.
“There is value in having a range of biometric devices connect to the Converged Health Management platform,” said Julie Kling, director of mobile health, Verizon. “With our new enhancements, Verizon is driving innovation for our clients by helping them to change how healthcare is delivered to patients," she said. “Verizon would like to continue to build an ecosystem of devices to create a diverse network of meaningful mobile health experiences that connect clinicians and their patients so they can be cared for in new and more effective ways."
Verizon Converged Health Management is designed for healthcare providers, health insurance and large private employers that are looking for ways to monitor at-home care compliance and engage patients in healthier lifestyle choices, all with the goal of helping clinicians reduce hospital readmissions.
Verizon provides an integrated fabric of health IT solutions that address the biggest challenges facing the U.S. healthcare system today, including the ability to securely and efficiently exchange sensitive patient data across hospital, payer and physician networks via voice, video and data. This includes interconnected cloud, mobility, machine-to-machine and security solution sets.
Verizon’s vision is to create a healthier world in which connected individuals and healthcare organizations are empowered with innovative technologies that improve health outcomes, transform access to care and lower the cost of healthcare.