Camber launches generic Nexium
PISCATAWAY, N.J. — Camber Pharmaceuticals on Wednesday announced the launch of its generic version of Nexium (esomeprazole magnesium) delayed-release capsules. The launch comes after Camber’s parent company, Hetero Labs received final approval from the Food and Drug Administration.
“Esomeprazole represents another very significant product in the growth of our organization, Camber president Kon Ostaficiuk said. “We are happy that patients have a more affordable treatment option.”
The drug is meant to treat heartburn, stomach ulcers, gastroesophageal reflux disease, and a damaged esophagus. It will be available in 20- and 40-mg capsules, both of which will be available in bottles of 30, 90 and 1000.
Calif. pharmacy board provides Rx support to wildfire evacuees
SACRAMENTO, Calif. — As both the Butte and Valley Fire raged in northern California, the state’s board of pharmacy held an emergency meeting to ensure that those affected by the blazes have access to medications. Last week, the board waived certain regulations for pharmacists in 18 counties containing and adjacent to the fire, allowing pharmacists to dispense medication to evacuees, even if their prescriptions aren’t on file with a particular pharmacy.
The move came as the two fires — which are slowly being contained and have collectively destroyed nearly 2,000 structures, burned more than 146,000 acres and killed two — forced thousands of people out of their homes and California Gov. Jerry Brown declared a state of emergency.
The emergency waiver allows pharmacists to dispense a 30-day supply of medically necessary drugs to a patient or pet, even without a prescription or empty container, excepting sterile compounded prescriptions and controlled substances. The waiver will stay in place until the state of emergency is lifted, California’s board of pharmacy said.
FDA approves Taiho Oncology’s Lonsurf
SILVER SPRING, Md. — The Food and Drug Administration on Wednesday announced the approval of Taiho Oncology’s Lonsurf (trifluridine and tipiracil). The pill, a combination of two drugs, is intended to treat metastatic colorectal cancer that has stopped responding to other therapies.
“The past decade has brought a new understanding around colorectal cancer, in how we can both detect and treat this often devastating disease,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “But there are many patients who still need additional options, and today’s approval is a testament to the FDA’s commitment to work with companies to develop new drugs in disease areas where unmet needs remain.”
Lonsurf marks the first FDA approval for Taiho Oncology.
“Patients with metastatic colorectal cancer, whose disease has progressed after treatment with standard therapies, have had limited therapeutic options to treat their disease,” Taiho president and CEO Eric Benn said. “Lonsurf helps address this unmet medical need by providing patients with a new therapeutic option that can help extend their overall survival.”