FDA
10th June 2013

FDA panel favors alleviating restrictions for AVANDIA

The RESULTS are in! A panel of FDA advisers thinks it is time to alleviate restrictions currently in place for the antidiabetic drug, Avandia (rosiglitazone). Of the 20 panelists who voted

FDA panel favors alleviating restrictions for AVANDIA

The RESULTS are in! A panel of FDA advisers thinks it is time to alleviate restrictions currently in place for the antidiabetic drug, Avandia (rosiglitazone). Of the 20 panelists who voted to remove or modify the current labeling and distribution center, 13 voted to modify it while the remaining 7 voted to remove the REMS entirely.

The one-time multimillion dollar blockbuster drug dropped dramatically in usage due to reports that it increased the risk of heart attacks. Back in 2010, the FDA placed severe restrictions on the drug following concerns that were raised regarding an increased risk of cardiovascular events; the European regulators banned the drug altogether. In this decision, the Agency required a re-examination of the drug manufacturer’s, GlaxoSmithKline (GSK), RECORD trial as the trial’s methods and reliability of results were questioned. This six-year study of 4,400 patients was the only large, randomized trial of rosiglitazone. Adjudication results were presented before the FDA panel this week for review, and put many of those concerns to rest according to many of the panelists.

Sanjay Kaul, MD, director of cardiovascular fellowship training at Cedars-Sinai Medical Center in Los Angeles, stated that there’s not enough evidence to support or blame rosiglitazone’s safety and therefore physicians should be able to choose it if they desire.

The decision is now in the hands of the FDA. The FDA is not obligated to follow the advice of its advisory committees but usually does.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

Recent Related Articles

Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission
01 July 2020
Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission

Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more

Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices
25 June 2020
Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices

FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more

NDA vs. OTC Monograph: Which Pathway is Right for You?
22 June 2020
NDA vs. OTC Monograph: Which Pathway is Right for You?

One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more

4 Problems Importing Rapid Antibody Tests for Coronavirus
19 June 2020
4 Problems Importing Rapid Antibody Tests for Coronavirus

US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more

Let’s work together

The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us today

Contact us