FDA issues complete response letter for MannKind’s Afrezza
VALENCIA, Calif. The Food and Drug Administration did not approve an application from MannKind Corp. for a drug to treat elevated blood sugar in diabetes patients, MannKind announced Monday.
The FDA gave the drug maker a complete response letter for Afrezza (insulin human [rDNA origin]) inhalation powder for adults with Type 1 and Type 2 diabetes. The FDA issues a complete response letter when it has completed review of an application, but still has questions that preclude approval in the application’s current form.
The FDA requested information and currently available clinical data to support the clinical utility of Afrezza and about the comparability of the commercial MedTone inhaler with the earlier version that was used in clinical trials. The FDA did not have any concerns about the drug’s safety, but it did ask for updated safety data while requesting changes to the drug’s labeling.
“We are currently reviewing the complete response letter and fully expect that we will be able to respond to the FDA’s requests in a timely manner,” MannKind chairman and CEO Alfred Mann said. “We had always planned to follow the original [application] for Afrezza with a regulatory submission for our next-generation inhaler rather than launch with the commercial version of the MedTone device.”
Students celebrate Rx Day
OLYMPIA, Wash. —Students from the schools of pharmacy at the University of Washington, in Seattle, and Washington State University, in Pullman, Wash., converged on the Washington state capitol in Olympia to mark the annual Pharmacy Day on Feb. 9. Students and pharmacists met with state legislators and offered them and their staff free health screenings.
Health Mart hits critical mass
SAN FRANCISCO —Chances are good that there’s a Health Mart in your community. Some four years after its reinvention as a cutting-edge, market-savvy pharmacy franchiser by owner McKesson, the hard-driving independent drug store network now operates in all 50 states and comprises one of the largest and fastest-growing pharmacy brands in America. With guidance from McKesson VP and Health Mart president Tim Canning, and a team of experienced marketing and merchandising hands, Health Mart has come a long way from its days as a dormant, 300-store remnant of the old FoxMeyer wholesale drug network purchased by McKesson in the early 1990s.
In January, Health Mart surged past another milestone when Trudell Health Mart Pharmacy in Dearborn, Mich., became the 2,500th independent pharmacy to join the franchise. That marks an 850% jump in store count over the past four years, according to McKesson.
“We joined Health Mart to take advantage of the innovative marketing, operational and patient care programs available. Then we found out we were the 2,500th pharmacy to go blue and green, which is exciting because we just celebrated 80 years of serving the community,” said Trudell owner Tom Fakih.
Among the reasons Trudell joined the franchise, Fakih said, were “new services and programs that help us better care for, educate and inform our patients,” including Health Mart’s recent “Health Across America” campaign to test people for diabetes risk.
To maintain its growth momentum, Health Mart has begun leveraging its national scale and reach. Early this year, the chain launched a national TV ad campaign tied to such major events as the Super Bowl, the Winter Olympic Games and the Academy Awards.
“Being ranked highest in customer satisfaction by J.D. Power and Associates, coupled with our growth to 2,500 pharmacies, is a further demonstration of Health Mart’s commitment to the local Health Mart pharmacists,” Canning said.