Acura Submits Acurox Briefing Package To FDA

Anonymous User | Login

Published: 06-Aug-2009

Acurox, with proposed indication for the relief of moderate-to-severe pain

King Pharmaceuticals has submitted a briefing package to FDA addressing the issues raised in the Agency's June 30 Complete Response Letter (CRL), related to the New Drug Application (NDA) for Acurox (oxycodone HCl/niacin) Tablets.

Acura and King Pharmaceuticals Research and Development (King) are scheduled to meet with FDA in late third quarter of 2009, to discuss the CRL and the briefing package.

Acurox is an immediate release tablet with a proposed indication for the relief of moderate-to-severe pain. Acurox incorporates Acura's Aversion Technology and is intended to discourage product misuse and abuse.

Acura and King are developing Acurox and three additional opioid analgesic products, utilizing Aversion Technology.

Wyeth' Enbrel Gets Positive European Recommendations

Currently approved for intermittent treatment of adult plaque psoriasis ...

Wyeth' Unit Launches Gender-Age-Specific Adult Multivitamin Line

Developed to help meet the nutritional needs of women and men ...

Sanofi-Aventis To Purchase Diabel Manufacturing Facility In Frankfurt

Scope of acquisition includes buildings, equipment, machinery and some existing contracts ...

Pfizer Enters Into Agreement With Kano State Government

Government to dismiss civil and criminal cases against the company ...

Pfizer' Reveals Results For Four Lung Cancer Trials

Pfizer has announced positive results from four studies highlighting clinical data with targeted treatment approaches in patients with non-small cell lung cancer. The ong ...

Pfizer Signs Research Partnership With SIBS

To support fundamental research in China ...

Pfizer Inks Marketing Pact With Claris

Pfizer has entered into a marketing agreement with Claris Lifesciences, an Indian firm specialising in injectables. As per the agreement, Pfizer gains marketing rights fo ...

Jubilant To Form Drug Development Collaboration With Endo Pharmaceuticals

Endo to own any compounds developed under the collaboration ...

Wyeth, ASKA, Takeda Report Changes In SELTOUCH's Japanese Sales, Distribution

SELTOUCH, a transdermal absorption-type analgesic and anti-inflammatory agent ...

Pfizer Reports Positive Results For Phase-III Sutent Trial

Demonstrated median progression-free survival of 11.1 months in patients with advanced pancreatic islet cell tumors ...

Network Sites

Contract Research Clinical Trials Contract Services Drug Delivery Drug Discovery & Development OTC Regulatory Affairs Process and Production IT and Software Laboratory Instrumentation Manufacturing Fine & Specialty Chemicals Medical Devices Business Review Inward Investment Packaging

Mail sent successfully

Tell your friend about this article

Please enter a valid email address

Please enter your name

Please enter the mail body

Your Name: *

Your Email: *

Friend's Email: *

Email Body: *: I thought you would be interested in this article : http://www.pharmaceutical-business-review.com/news/acura_submits_acurox_briefing_package_to_fda_090806/

Suppliers To This Sector

Browse A-Z

# A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Almac

Drug Development Solutions ...

STARLIMS

Benefits for Life Science Labs ...

Parenteral Drug Association (PDA)

Pharmaceutical Information and Education Services ...

Burkert Fluid Control Systems

Fluid and Gas Control Systems ...

IMCOR

LIMS and Laboratory Informatics Consultancy ...

Umicore Precious Metals Chemistry

Chemicals and Catalysts for Industrial Applications ...

White Papers

Browse A-Z

# A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Related Companies

Elan Corporation, plc

Elan Corporation, plc (Elan) is an Irish based biotechnology company, incepted in 1969. ...

Par Pharmaceutical Companies, Inc.

Par Pharmaceutical Companies, Inc. (Par Pharmaceutical) is a pharmaceutical company eng ...

Endo Pharmaceuticals Holdings Inc.

Endo Pharmaceuticals Holding Inc. (Endo) is a pharmaceutical company focused on the res ...

Purdue Pharma L.P.

Purdue Pharma L.P. (Purdue) is a privately held pharmaceutical company. It is principal ...

Pfizer Inc.

Pfizer Inc. (Pfizer) is a global research based pharmaceutical company principally focu ...

Suppliers Product News

Almac Completes Phase One of Its Expansion Plan to Pharma Services Facilities

New $15m facility will "meet growing business need for its integrated product development and commercial services."

Free Newsletter Sign-up

Sign up, and we will send you a free Pharmaceutical report on “ Combination Products – Evolution of the Medical Equipment Industry” from GlobalData worth $750