Acurox's New Drug Application discussed with the FDA

Editorial Checklist Reviewed
Sep 4 2009NewsGuard 100/100 Score

Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) and King Pharmaceuticals, Inc. (NYSE: KG) announced today that they met with the U.S. Food and Drug Administration ("FDA") on September 2, 2009 to discuss the FDA’s June 30, 2009 Complete Response Letter regarding the New Drug Application for Acurox® (oxycodone HCl and niacin) Tablets CII (NDA).

The FDA and the Companies agreed to take the NDA to an FDA Advisory Committee to consider the evidence to support the potential opioid abuse deterrent effects of Acurox® Tablets. The FDA indicated that no new clinical trials are required at this time. The FDA has not yet set a meeting date for the Advisory Committee’s review of the NDA. The Companies do not expect the meeting to be convened before the end of this year.

Source:

http://acurapharm.com/

Posted in: Pharmaceutical News

Tags: , , , , , ,

Comments (0)

Suggested Reading

Not all ultra-processed foods are made alike: Researchers warn against villainizing entire food group
Living in food deserts during early childhood raises long-term obesity risk
Social media normalizes unhealthy food choices, shaping youth habits and brand loyalty
Online food shopping: Are you getting the information you need?
Key triggers for food allergies in children after organ transplants
Ultra-processed foods dominate children's diets from toddlerhood to middle childhood
High levels of microplastics found in prostate tumors, possibly linked to take-out food
Limiting fast-food outlets can reduce childhood overweight and obesity

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
(Logout)
Post

Newsletters you may be interested in

See all Newsletters »

Terms

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

Provide Feedback

You might also like...
Six common flying with food allergies myths