Content about Food and Drug Administration

NEW YORK — The spate of recent product recalls may be eroding consumer confidence in the Food and Drug Administration, according to a PricewaterhouseCoopers survey of 1,000 Americans released Tuesday.

Approximately one-half of respondents reported they think the FDA does a good job, but more than one-third (36%) of U.S. consumers said they have lost confidence in the FDA over the past two years as a result of high profile safety concerns and product recalls.

NEW YORK — Recent public perception that the Food and Drug Administration had not been doing its job — ensuring that Americans' approved medical devices and medicines are relatively safe — may be impeding fast approval processes, according to a new PricewaterhouseCoopers report published Tuesday.

The report, “Improving America’s Health V,” determined that the FDA’s renewed vigor for enforcing regulations may be straining the working relationship between regulator and the industry being regulated.

ROCKLAND, Mass. — The Food and Drug Administration has extended its review period for a multiple sclerosis drug made by EMD Serono, the drug maker said Friday.

EMD Serono — the U.S. subsidiary of German drug maker Merck KGaA, which uses the name to avoid confusion with U.S.-based Merck — said the FDA had extended the review time for cladribine tablets to Feb. 28. The drug is a disease-modifying drug for relapsing MS.

HAYWARD, Calif. — Generic drug maker Impax Labs is challenging the patent covering a drug used to treat high cholesterol, the company said Friday.

Impax said it had filed an approval application with the Food and Drug Administration for niacin and simvastatin extended-release tablets in the 1,000 mg/20 mg strength. The drug is a generic version of Abbott Labs’ Simcor.

HAYWARD, Calif. A generic drug maker confirmed a patent challenge for its version of a branded cholesterol drug that recently was submitted to the Food and Drug Administration for approval.

Impax said Daiichi Sankyo and Genzyme are seeking to block Impax's generic version of Welchol (colesevelam HCl) for oral suspension, in 3.75 g/packet and 1.875 g/packet strengths. The two drug makers filed suit for patent infringement against Impax in the U.S. District Court for the District of Delaware after being notified that the FDA accepted Impax's ANDA for the drug.

COLORADO SPRINGS, Colo. Several organizations representing retailers and consumer healthcare product manufacturers want Congress to reverse a provision in the healthcare-reform act that would prohibit the use of flexible spending accounts to purchase over-the-counter medicines without a prescription.

SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for preventing skeletal injuries in patients whose cancer has spread to the bone.

The FDA announced Friday the approval of Thousand Oaks, Calif.-based biotech company Amgen’s Xgeva (denosumab) for bone metastases.

NEW YORK — Johnson & Johnson and the U.S. government are suing two generic drug makers to stop them from launching a generic drug for HIV, according to published reports.

Bloomberg reported Thursday that Tibotec, a subsidiary of J&J, and the government were separately suing Mylan and Lupin over a generic version of the drug Prezista (darunavir ethanolate), alleging patent infringement.

SILVER SPRING, Md. — A class of alcoholic beverages that rapidly became popular among young people over the last few years is headed for the drain.

The Food and Drug Administration issued warning letters to four manufacturers of beverages that combine high amounts of alcohol and caffeine, effectively issuing a federal ban on the beverages.

SILVER SPRING, Md. — The Food and Drug Administration on Monday teamed up with the Centers for Disease Control and Prevention and other healthcare professionals, government, academic, international and industry partners to support Get Smart About Antibiotics Week, Nov. 15 to 21, as part of a joint effort to encourage the appropriate use of antibiotics.

LAVAL, Quebec — Generic drug maker Actavis has filed for approval of a generic version of an antidepressant made by Canada’s Labopharm, Labopharm said.

The drug maker said it received a notification stating that Actavis had applied to the Food and Drug Administration for approval of a generic version of Oletpro (trazodone hydrochloride) extended-release tablets in the 150-mg and 300-mg strengths.

SAN DIEGO — The Food and Drug Administration has granted orphan drug designation to a drug for treating sickle cell disease.