FDA opens (Docket No. FDA-2014-N-0198) Monday March 10th - “Withdrawal of Approval of 8 new Drug Applications and 46 Abbreviated New Drugs for Propoxyphene Products”

Today - March 10^th - (FDA (Food and Drug Administration) - will publish a notice in Federal Register http://1.usa.gov/1n7WmSH

At this link http://1.usa.gov/1h4LRIp you will find the whole letter published by FDA.

I quote the following text from the letter written b y FDA;  

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 8 new drug  applications (NDAs) and 46 abbreviated new drug applications (ANDAs) for prescription pain medications containing propoxyphene. The holders of these applications have agreed in writing to permit FDA to withdraw approval of the applications and have waived their opportunity for a hearing.

Propoxyphene is an opioid pain relief medication marketed under brand names such as Darvon and Darvocet. 

In 1957, FDA approved NDAs 010996 and 010997 for propoxyphene hydrochloride (HCl), alone and in combination with other active ingredients, both of which are currently held by Xanodyne Pharmaceuticals, Inc. (Xanodyne).

In 2010, after receiving new clinical data showing that when propoxyphene is taken at therapeutic doses, the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities, and other information including new epidemiological data, FDA concluded that the risks of propoxyphene outweigh its benefits as a pain reliever. In separate telephone conversations on November 18, 2010, FDA asked Xanodyne and the holders of marketed generic propoxyphene drug products to permit FDA to withdraw approval of their applications and to waive their opportunity for a hearing. 

In a separate notice published elsewhere in this issue of the Federal Register, FDA notifies other holders of ANDAs for pain medications containing propoxyphene  if they wish to challenge the Agency’s proposal to withdraw approval of their applications.

Xanodyne and manufacturers of generic propoxyphene products identified in table 1 have written to FDA asking the Agency to withdraw approval of their applications for propoxyphene- containing products and have waived their opportunity for a hearing. Some products approved under the applications identified in table 1 were discontinued in the past, before FDA’s November 2010 determination that the risks of propoxyphene outweigh its benefits. Not included in table 1 are NDAs and ANDAs for which Federal Register notices were previously published announcing withdrawal of approval.”

Propoxyphene banned Nov 19^th 2010

It is well-known that the substance Propoxyphene (Darvon & Darvocet)– was banned Nov 19^th 2010. The day before - Nov 18^th- FDA was in telephone-contact with Xanodyne and the holders of marketing generic propoxyphene drug products to permit FDA to withdraw approval of their opportunity for hearing.

There have been some question-marks around the banning of the substance Propoxyphene.

There are many questions about how this ban has been handled. Although there are more than three years and three months after the ban came into force has not yet the federal judge Danny C Reeves decided how it will be with future trials.

At a meeting on Monday, January 7 of this year, Judge Reeves met a couple of the court appointed attorneys - who represented the more than 100 attorneys who are expected to participate in future trials. Two of these were Richard W Shulte from Dayton , Ohio, and Matthew J. Herring from Edmond, Oklahoma.

Still, Judge Reeves have not officially reported any decision from this meeting - even though it is now eight weeks since the meeting took place.

As I recently wrote in another post in my blog, I reported that the consumption of the prohibited drugs Darvon and Darvocet has increased by 145% from 2011 to 2012 from 5227 kg to 12.841 kg .

Surely you can understand that some relatively few people - for a short time - can have access to the drug in the license.

But when a drug is banned by its toxicity should such a ban be upheld.

Another issue that should be addressed is the note that the FDA will publish today, we have written about in this blog post. One guess is that the FDA believes that the parties involved - both the court that the lawyers representing both sides in the coming trials - have difficulty agreeing on the trials will be conducted. A question like this cannot be delayed as long as you completely because of legal wrangling.