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:3/24/2017)... PUNE, India , March 24, 2017 ... conjugates market has been growing rapidly as the global sales of ... Globally, the growth in the antibody drug conjugates market is driven ... incidences of cancer and wider therapeutic window offered by ADCs. ... Browse 3 Tables and ...
(Date:3/24/2017)... INDIANAPOLIS , March 24, 2017  Eli ... today announced plans to invest $850 million in ... span facilities across its U.S. enterprise, including research ... The investments are being driven by demand for ... of potential medicines in development targeting cancer, pain, ...
(Date:3/24/2017)... The Board of Directors of Nordic Nanovector ASA (OSE: ... complete 2016 Annual Accounts with notes. The report is attached ... the section Investor Relations/Reports and presentations/Annual Reports. ... For further information, please ... Cell: +47-91-51-95-76 Email: ir@nordicnanovector.com Media enquiries: ...
Breaking Medicine Technology:
(Date:3/24/2017)... ... March 24, 2017 , ... In just two ... Frame vertical micro-veggies garden on Kickstarter . Surpassing the $100,000 milestone so ... nearly 2,000 consumers (and counting) already backing the campaign. , “We are ...
(Date:3/24/2017)... ... ... Viewers who like to educate themselves on current issues and who enjoy ... societal issues tend to appreciate and love the "Informed" series, hosted by Rob Lowe. ... for causes around the world. , Running for charity has become a ...
(Date:3/24/2017)... ... 24, 2017 , ... “End Time GPS”: a dauntless and enlightened study ... Time GPS” is the creation of published author, Wesley Gerboth, a World War II ... and space-vehicle projects. Now, at age ninety-one, he shares the Wisdom God bestowed upon ...
(Date:3/23/2017)... ... March 23, 2017 , ... A recent report from the National Council on ... The NCTQ report suggests, based on a review of GPA and SAT/ACT requirements at ... in the U.S. It argues that this higher bar should be set by states, ...
(Date:3/23/2017)... ... March 23, 2017 , ... The IoT (Internet of Things) is revolutionizing ... a huge impact on businesses and individual consumers alike. Laboratories can maximize their ... a value anywhere from $4 trillion to $11 trillion dollars by the year 2025. ...
Breaking Medicine News(10 mins):