Why is Ambroxol not approved by the FDA?

Why is Ambroxol not approved by the FDA when it is readily available in Europe in countries with higher safety standards? Does anyone know the history that lead to this? And does anyone have knowledge of whether this will be changing?

[park_bear]

Ambroxol is available in the US over-the-counter which would imply an FDA approval.

amazon.com/s?k=ambroxol

[Hidden in reply to park_bear]

Unexpected Infant Deaths Associated With Use of Cough and Cold Medications

pediatrics.aappublications....

"We emphasize that ambroxol is not approved for prescription or OTC use by the US Food and Drug Administration (FDA) for any indication and cannot be legally marketed in the United States."

Thus I believe it is illegally sold through Amazon.

[park_bear in reply to Hidden]

Thanks for the correction

[Hidden in reply to Hidden]

FYI, I also recall seeing a post on HU from someone who ordered Ambroxol recently and it was stopped by US customs... One of the things they were asking for was proof of a prescription....

[kevowpd in reply to Hidden]

You tip 'em off? 😋

"Let's see the tap test results please"

[Despe in reply to Hidden]

Amazon is selling illegal cough syrup??? When FDA pulled their ears for selling NAC, they got it off the shelves fast!

[Hidden in reply to Despe]

Hi Despe, I wonder who is legally liable for selling illegal drugs, Amazon or the actual seller.

[Despe in reply to Hidden]

I have the same question about vaccine deaths. However, Amazon have their team of lawyers, too. They could be held liable even for their supplier.

Maybe Jim in our forum can answer your question.

[Despe in reply to Hidden]

Deaths from vaccines, too. . .

[grower in reply to Despe]

In the US the current rate is .00018% or about 6,000 people out of 340million vaccinations that have been reported to have died after covid vaccination but those can be submitted by anybody and do not prove causality. You might be confused with numbers released by U.S. Vaccine Adverse Event Reporting System that seems to be doing the rounds, and that covers all reports of all adverse effects, not just deaths, and of all vaccines not just COVID vaccines.

[Despe in reply to grower]

Thanks for your reply. However, I have my sources, too. . .

[egerio in reply to Hidden]

The FDA has not approved Ambroxol because no company is willing to invest in the testing process required for approval of a generic drug.

If PD were elevated to the status of Covid-19, the CDC would be falling all over itself, wondering how to get people to try it and the government would be recruiting drug companies to run trials of the drug.

[Cocomann25 in reply to park_bear]

it is not.

[Bolt_Upright]

Maybe Ambroxol can't compete with our lower priced lower standards cough medicine. Ambroxol is made in Germany. I am pretty sure where all of our cough medicine is made.

[felixned]

To answer your original question cclemonade it isn't patentable in US and thus there is no incentive to invest in the FDA approval process

[Hidden]

I have not found any specific reason that Ambroxol has not been approved by the FDA, nor can I find any evidence that it was ever submitted for approval by Boehringer Ingelheim who first patented it and marketed it in Europe successfully (and still does as Mucoangen and Lysopain) as a cough medicine/expectorant in the 70's. It has been off patent for many years now, and I would agree with Felixned, there is likely not enough financial incentive for big pharma to pursue its approval in the US as a cough med when it would likely take share from their patented name brands (like Mucinex & Robitussin). This clinical trial quote seems to confirm that:

"Ambroxol hydrochloride is an oral mucolytic drug available over-the-counter for many years as cough medicine. In 2009 it was found to also act as a pharmacological chaperone (PC) for mutant glucocerebrosidase, albeit in a several-fold higher dose. Unfortunately, due to its low cost, there have been no pharma-driven clinical trials to establish the use of ambroxol. Thus, data are needed on the safety and efficacy of ambroxol for patients with Gaucher disease (GD)."

clinicaltrials.gov/ct2/show...

So it has been left up to a variety of independent groups and medical centers to do the research work on it for other conditions like PD that big pharma will not (instead they focus on researching some of their patented bands as repurposed meds for PD, some of which you know like Exenatide, and many of which have more serious potential side effects). All of which takes more time than it would otherwise, and in the meantime we progress and are forced to make decisions for ourselves.

[egerio]

Here's my theory as to why Ambroxol is not over the counter in the US. As I recall, Congress said that any medicine available to the public without prescription before 1973 (?) was Generally Recognized As Safe (GRAS), so medications like aspirin were sold without regulation. Ambroxol came to market in 1977(?) and had to go through extensive=expensive testing before it could be sold in the US. Meawhile Ambroxol went off patent and it made no economic sense to go through the testing required to get FDA authorization.

It's interesting to me that the British and Canadians are testing Ambroxol for PD. My assessment is that their systems are oriented to delivering health to their people at low cost. The FDA refused to work with the Canadians on their study of Ambroxol for patients with PD Domentia. Our system seems to be oriented to delivering profits to drug companies.