Abbott Receives Complete Response Letter From FDA for Controlled-Release Hydrocodone With Acetaminophen
2008年10月21日 - 5:35AM
PRニュース・ワイアー (英語)
ABBOTT PARK, Ill., Oct. 20 /PRNewswire-FirstCall/ -- Abbott has
received a Complete Response Letter from the U.S. Food and Drug
Administration (FDA) for its New Drug Application (NDA) for a
controlled-release form of hydrocodone with acetaminophen. Abbott
is evaluating the FDA Complete Response Letter, will discuss the
letter with the FDA, and will provide an update when appropriate.
Abbott is seeking the approval of controlled-release hydrocodone
with acetaminophen as the first extended release medication in the
class to provide extended relief over 12 hours; currently available
short-acting hydrocodone and acetaminophen (HC/APAP) medications
must be taken every four to six hours. Abbott is confirming its
earnings-per-share forecast for the fourth quarter and full-year
2008. In addition, the company continues to expect double-digit
earnings-per-share growth in 2009. About Abbott Abbott is a global,
broad-based health care company devoted to the discovery,
development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics.
The company employs more than 68,000 people and markets its
products in more than 130 countries. Abbott's news releases and
other information are available on the company's Web site at
http://www.abbott.com/. DATASOURCE: Abbott CONTACT: Media, Melissa
Brotz, +1-847-935-3456, or Scott Stoffel, +1-847-936-9502, or
Financial, John Thomas, +1-847-938-2655, or Lawrence Peepo,
+1-847-935-6722, all of Abbott Web site: http://www.abbott.com/
Copyright