Fentora’s expanded label nixed by FDA panel
WASHINGTON A Food and Drug Administration panel voted against broadening the label for Cephalon’s pain drug Fentora, according to the Associated Press.
The drug is approved to treat breakthrough pain in cancer patients. The company is looking for the drug to be approved to treat sudden pain bouts in non-cancer patients.
The panel voted yesterday 17 to 3 against expanding the label, but the panel’s tone was said to be positive, which could give Cephalon an opportunity to win FDA approval for the expanded label.
While the panel could have recommended outright rejection for the request, it recommended further study instead. Cephalon has already started a trial comparing Fentora to an instant-release form of the drug oxycodone.
Cephalon expects the FDA to make a final decision by Sept. 13.
Fougera gets FDA approval for generic Dovonex
MELVILLE, N.Y. The Food and Drug Administration has granted approval to Fougera for its generic version of the Warner-Chilcott’s psoriasis drug Dovonex. The drug is indicated to treat chronic, moderately severe psoriasis of the scalp.
The generic, calcipotriene topical solution 0.005 percent is available in a 60 mL bottle.
According to Warner-Chilcott, Dovonex had sales of $145.3 million in 2007.
“Fougera has received more FDA approvals for topical products during the past seven years than any other generic company. Today’s announcement that we are first-to-market with Calcipotriene topical solution is another example of our ongoing commitment to provide safe, effective and affordable options to health care providers and their patients,” stated David Klaum, Fougera’s senior vice president of commercial business operations.
FMI leaders stress health and wellness at annual meeting
LAS VEGAS Growing awareness of nutritional issues, wellness and preventive health among consumers has handed the supermarket industry a golden opportunity to build stronger ties to the U.S. population and a stronger business model, leaders of the Food Marketing Institute told members at the group’s annual meeting.
Held alongside the 2008 FMI Supermarket Pharmacy Conference, the food-store industry’s biggest annual gathering showcased the growing movement in healthier eating and wellness—and in the rapid integration of in-store supermarket pharmacies with the food offerings out front. That point was brought home in a series of speeches and seminars for both supermarket pharmacy and grocery executives, and on display among vendors on the massive trade floor of the Mandalay Bay Convention Center.
Leaders of both FMI and its growing pharmacy division stressed the opportunity for food- and combo-store retailers to capitalize on Americans’ rising clamor for healthier eating alternatives. Consumers are demanding both nutritional advice, said FMI president and chief executive officer Tim Hammonds, and pharmacists who can bridge the gap in the supermarket between medicinal counseling and nutritionally driven wellness programs.
“Health and wellness … is a space that supermarkets can own,” Hammond told members. “This is a great opportunity … connecting the dots between health and wellness.”
Supermarkets that contain in-store pharmacies, Hammonds added, also derive “a tremendous halo effect from the pharmacist being there.”
The current economic downturn can also spell opportunity for supermarket retailers, said Hammonds, who announced plans to retire after a successor is named, following 15 years as head of the organization. “Food retailers can turn these economic challenges into benefits for consumers and the industry,” he said. “As people eat out less often, we can help revive the great American home family meal tradition.”
FMI’s decision to hold its main industry gathering and its annual pharmacy conference side-by-side gave the industry’s pharmacy leaders a chance to review health and wellness options alongside their food-store counterparts. It also gave them the chance to meet with the organization’s first vice president of pharmacy services, Catherine Polley.
Polley joined FMI in September after a career with the National Association of Chain Drug Stores, the American Pharmacists Association and Kmart Corp. The group’s annual pharmacy powwow was her first chance to address supermarket pharmacy leaders at the event since being named to the new post.
Addressing supermarket pharmacy leaders, Polley stressed the need to integrate pharmacy and wellness with the nutritional advantages offered by supermarkets. She also recapped the top challenges facing food-store pharmacy, including shrinking Medicaid reimbursements and patient compliance.