Navigation Links
Abbott Receives Complete Response Letter From FDA for Controlled-Release Hydrocodone With Acetaminophen
Date:10/20/2008

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.


'/>"/>
SOURCE Abbott
Copyright©2008 PR Newswire.
All rights reserved

Page: 1

Related medicine technology :

1. Abbotts XIENCE V(TM) Drug Eluting Stent Outperforms TAXUS(R) in Key Efficacy and Safety Endpoints Out to Two Years
2. Continuous Treatment With Abbotts HUMIRA(R) Achieves Superior Long-Term Efficacy for Psoriasis Patients Compared to Interrupting Treatment
3. Abbotts Kaletra(R) Tablet Dosed Once-Daily or Twice-Daily Demonstrated Similar Clinical Results Across Race and Gender Lines
4. Abbotts Phase III Sub-Group Analysis Shows Investigational TriLipix(TM) in Combination with CRESTOR(R) Improves Key Lipids in Patients with Mixed Dyslipidemia and Type 2 Diabetes
5. Phase III Study of Abbotts Investigational TriLipix(TM) in Combination With AstraZenecas CRESTOR(R) Meets Primary Endpoints on Key Lipids
6. Abbott Presents Long-Term Data From Extension Study Showing Adult Crohns Patients Treated With HUMIRA(R) (Adalimumab) Maintained Remission
7. XIENCE(TM) V Drug Eluting Stent from Abbott Outperforms Market-Leading Stent in Reducing Major Adverse Cardiac Events at Two Years
8. Study in JAMA Shows Patients Treated With Abbotts XIENCE(TM) V Drug Eluting Stent Experience Better Outcomes Than Patients Treated With Market-Leading Drug Eluting Stent
9. Abbotts Phase III Studies of Investigational TriLipix(TM) (ABT-335), in Combination With Statins, Meets Primary Endpoints on Improving LDL, Triglycerides and HDL
10. Abbotts XIENCE(TM) V Drug Eluting Stent Demonstrates Consistent and Positive Clinical Outcomes Out to Two Years
11. Abbotts HUMIRA(R) (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... 11, 2017  True Health, a leader in ... effort during National Breast Cancer Awareness month to ... Research recently ... that more than 10 million American women are ... BRCA1 or BRCA2 and have not had testing. These ...
(Date:10/7/2017)... Oct. 6, 2017   Provista, a proven ... $100 billion in purchasing power, today announced a new ... The Newsroom is the online home for ... infographics, expert bios, news releases, slideshows and events. ... a wealth of resources at their fingertips, viewers can ...
(Date:10/4/2017)... Oct. 4, 2017 OBP Medical ... illuminating medical devices, today announced regulatory approval from ... Agency (or Agência Nacional de Vigilância Sanitária (ANVISA)) ... cordless surgical retractor with integrated LED light source ... illumination and exposure of a tissue pocket or ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out many kids ... sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting kids excited ... all ages; it is a non-competitive, non-timed event, which is all about having fun ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains ... possible to save lost souls in the Philippines. “The Journey: From the Mountains to ... dedicated teacher of the Bible. She has taught all ages and currently teaches a ...
(Date:10/12/2017)... ... 2017 , ... Planet Fitness, one of the largest and fastest growing franchisors ... a flagship location in Covington, LA at 401 N. U.S. Highway 190, in January ... Office Depot in the Holiday Square shopping center. Its location allows it to serve ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts ... Washington, D.C., for the 49th Congress of the International Society of Paediatric Oncology ... of the Center for Cancer and Blood Disorders at Children’s National, and ...
Breaking Medicine News(10 mins):