Citing potential problems, FDA declines to approve A.P. Pharma drug
REDWOOD CITY, Calif. The Food and Drug Administration raised a number of concerns that it said precluded the approval of a drug made by A.P. Pharma for preventing sickness in patients taking chemotherapy, A.P. said Friday.
A.P. has been trying to win approval for APF530, for preventing acute and delayed-onset chemotherapy-induced nausea and vomiting, but the FDA issued the company a complete response letter. The FDA issues complete response letters when the review of a file is completed, but questions remain that don’t allow it to grant final approval.
Specifically, the FDA cited potential problems with the two-syringe dosing system of the drug and potential transfer of material from one syringe to the other. There were also problems with A.P. Pharma’s manufacturing of the drug, according to the letter, including unspecified “deficiencies” found during an FDA inspection of the company’s factories, and the sterilization methods used. The agency didn’t ask for additional efficacy studies, but did ask for re-presentation and re-analysis of existing phase-3 clinical trial data and additional studies related to bioavailability and metabolism.
Rite Aid accepting EBT cards, food stamps at stores
CAMP HILL, Pa. Rite Aid on Thursday announced that all Rite Aid pharmacies now accept EBT (electronic benefit transfer) cards and food stamps provided through the Supplemental Nutrition Assistance Program.
“One-in-eight Americans are receiving food assistance through SNAP, according to the USDA,” stated Brian Fiala, Rite Aid EVP store operations. “With nearly 4,800 Rite Aid stores nationwide offering assorted groceries, accepting EBT cards is just another convenience we can offer to our customers and help make their lives a little easier.”
SNAP, formerly known as the Food Stamp Program, is administered by the USDA and offers families and individuals at certain income levels financial assistance in purchasing food and beverages. Electronic Benefits Transfer is the electronic system that allows a SNAP recipient to authorize transfer of their government benefits from a federal account to a retailer account to pay for products received. SNAP benefit recipients are issued EBT cards that look like debit cards.
Report: Food Lion pulls plug on Bloom stores expansion
RALEIGH, N.C. Food Lion has pulled its plans to bring four Bloom stores to the North Carolina market, according to local reports.
The four stores, which currently are under construction, will become Food Lions instead. Spokeswoman Christy Phillips-Brown said the company will focus on increasing the number of Bloom stores in existing markets rather than expanding into new ones.
The Bloom chain, which was introduced in 2004, has 66 stores, including one opening in Charlotte this week. The stores are known for such tech-savvy features as scanner guns and recipe kiosks.