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Concordia International - Key US Product Donnatal Has Extreme Regulatory Risk - May Put The Business At Risk 2 comments

Concordia International has a significant regulatory risk brewing in its key US Asset Donnatal. We intend to highlight the following below:

  • Donnatal is currently under review by the FDA and its marketing privileges may be in danger
  • The FDA does not likely believe that the product has proven itself to be effective in any clinical trials
  • The product very well may pose a risk to the public given that it contains Phenobarbital (a barbiturate), thus has abuse potential, and has no clinical data to support a marketing claim


Concordia International is a specialty pharmaceutical firm based in Canada with a Bermuda tax haven who's business model is to lever up in order to buy older generic product and then raise the price of those generic products to justify the extreme amount of leverage they have taken on. If this sounds like Valiant to you one might want to consider the comments the CEO made on television a few months ago:

Their price gouging in the UK has been well documented by The London Times and The Financial Times respectively:

While the World awaits the Nationalized Health system in the UK to cut these products from formulary, we have been concentrating on the risks to the US business - mainly their key product Donnatal.

Donnatal Regulatory Correspondence Has Become Concerning

Let's start by establishing that Donnatal - first marketed in the 1930's - has never established clinical efficacy in any indication (according to the FDA). At one point in the 1980's the product was granted an official approval, but the FDA quickly rescinded that approval due to a lack of clinical trail data. it has maintained its ability to be marketed because of a Byzantine set of regulations that left the product on market under what's called a conditional ANDA. Theoretically the company was supposed to prove that the product has some level of...