CareFusion Gets Approval to Change Antiseptic Labeling

The U.S. Food and Drug Administration (FDA) has approved CareFusion Corporation’s request to update the labeling to indicate reduced dry times on its Chloraprep products. Chlorarep is a broad-scale antiseptic for minor and major medical procedures and acts rapidly on a wide spectrum of bacteria. Following the announcement, shares of the company rose 2.8 percent to $38.99, after the market closed on Nov. 13.

The reduced dry times apply to several Carefusion Chloraprep products, including Sepp, Frepp, Single and Triple Swabsticks. These products have a reduced dry time on dry surgical sites of 30 seconds and a dry time on moist surgical sites of one minute. They are no longer labeled for electrocautery procedure.

CareFusion has also updated dry time changes to 30 seconds for dry sites and one minute for moist sites (for procedures not using an ignition source) in its Chloraprep 3 mL applicators.

However, dry times for procedures that use an ignition source remain unchanged at a minimum of three minutes on hairless skin and up to one hour in hair. Labeling for 10.5mL and 26 mL applicators of Chloraprep also remain unchanged.

CareFusion posted flat adjusted earnings per share of 44 cents for the first quarter of fiscal 2014 compared with the comparable quarter a year ago. Adjusted net earnings fell marginally by 3 percent to $96 million from $99 million a year ago.

Revenues in the quarter dipped marginally by nearly 1 percent (both in reported and constant currency) to $830 million. The decrease was driven by a fall in Medical Systems revenues.

The San Diego, Calif.-based company makes medical technology in the infection prevention and respiratory spaces, as well as medication management systems and operating room efficiency products.