Regulatory and Washington

GLENVIEW, Ill. — Mead Johnson's infant formulas, including Enfamil Premium Newborn, are safe, according to results of testing by both the Food and Drug Administration and the Centers for Disease Control and Prevention. These tests confirmed that the Mead Johnson products were safe, and no presence of the Cronobacter (Enterobacter sakazakii) bacteria was detected.

Rather than take off for Christmas, the editors of Drug Store News took a look at the year ahead and the stories, issues and trends that will make headlines in retail pharmacy in 2012.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday urged consumers to carefully read the labels of liquid acetaminophen marketed for infants to avoid giving the wrong dose to their infants. Giving more than the recommended dose of acetaminophen can cause serious side effects and possibly death, the agency warned.

MOUNTAIN VIEW, Calif. — The Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee is set to review an investigational treatment for obesity.

Biopharmaceutical company Vivus said the panel will review its new drug application for Qnexa on Feb. 22, 2012.

Meanwhile, the FDA will complete its review of the NDA for Qnexa on April 17, 2012. The regulatory agency accepted the NDA in November after Vivus' resubmission of the NDA in October.

GLENVIEW, Ill. — So far two retailers — Supervalu and Walmart — have pulled lots of Emfamil Premium Newborn powdered formula before any recall has been issued after learning of an infant's death this past weekend, according to published reports.

FORT WASHINGTON, Pa. — McNeil Consumer Healthcare on Wednesday issued a voluntarily recall of certain lots of Motrin IB coated tablets from retailers. "This is not a consumer-level recall, which means that consumers do not need to dispose of or return the product," McNeil stated. 

McNeil is recalling these products because testing of product samples showed that some caplets may not dissolve as quickly as intended when nearing their expiration date.

WASHINGTON — Larry Hausner, the CEO of the American Diabetes Association, will serve as the 2012 chairman of the National Health Council's board of directors, NHC said.

BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched its generic version of a drug designed to treat seizures in adults and children with epilepsy.

The generic drug maker said it received approval from the Food and Drug Administration on Dec. 16 for felbamate oral suspension in the 600-mg/5-mL strength. The Amneal generic is available in two sizes, 8 fl. oz./240 mL and 16 fl. oz./473 mL. It is a generic version of Meda Pharmaceuticals' antiepileptic Felbatol.