FDA approves two new drugs for pancreatic disorders
SILVER SPRING, Md. — The Food and Drug Administration has approved two new drugs for pancreatic disorders, the agency said Thursday.
The FDA announced the approval of Aptalis Pharma’s Ultresa and Viokase, both generically known as pancrelipase. Ultresa is a delayed-release capsule for children and adults with cystic fibrosis, which affects the lungs and other organs, while Viokase is meant for use with a proton-pump inhibitor in adults who can’t digest food because of pancreatitis or surgical removal of the pancreas.
"The approvals of Ultresa and Viokase, along with the other approved pancreatic enzyme products, allow healthcare providers to prescribe the product that is most appropriate for the estimated 200,000 patients in the United States who have pancreatic insufficiency," Office of Drug Evaluation III director Julie Beitz said.
FDA approves first flu vaccine to treat four strains of virus
SILVER SPRING, Md. — The Food and Drug Administration has approved what it called the first flu vaccine to prevent four strains of the influenza virus.
The agency announced Wednesday the approval of MedImmune’s FluMist Quadrivalent, which contains two influenza A and two influenza B strains. The currently approved version of FluMist is trivalent, containing two influenza A strains and one B strain, as are the other FDA-approved vaccines. The FDA said that in any given year, there may be two influenza B strains, or the strain in the vaccine may not be the one circulating.
"Illness caused by influenza B virus affects children, particularly young and school-aged, more than any other population," FDA Center for Biologics Evaluation and Research director Karen Midthun said. "A vaccine containing the four virus strains most likely to spread and cause illness during the influenza season offers an additional option to aid in influenza prevention efforts."
Federal court upholds DEA action against Cardinal Health
COLUMBUS, Ohio — A federal court has turned down Cardinal Health’s request for an injunction against the Drug Enforcement Administration’s suspension of the its ability to ship controlled medications from one of its distribution centers, the company said Wednesday.
Reggie Walton, a judge for the U.S. District Court for the District of Columbia, ruled against Cardinal’s request to enjoin the DEA from preventing the company from shipping controlled substances from the distribution center, in Lakeland, Fla.
Cardinal said it planned to appeal the decision to the U.S. Court of Appeals for the District of Columbia Circuit.
"We have demonstrated a deep commitment to helping fight prescription drug abuse," a statement from Cardinal read. "We work hard to actively prevent drug diversion and have spent millions of dollars to build a system of advanced analytics and on anti-diversion specialists. We have stopped distribution to hundreds of pharmacies determined to pose an unreasonable risk of diversion. The majority of those pharmacies still maintain their DEA registrations to dispense controlled medicines."
The DEA suspended the Lakeland distribution center’s registration to distribute controlled substances earlier this month, alleging that four of the 2,500 retail pharmacies it serves dispensed prescriptions for them illegally and that the company failed to ensure that the drugs were not diverted, though Cardinal said the allegations were wrong.