Enforcement Report - Week of August 9, 2023
is a Dublin, Ireland-based company that merged with France-based Flamel Technologies recently. Avadel has few approved drugs like Bloxiverx (neostigmine inj.), Vazculep (phenylephrine inj.), and Alkovaz (ephedrine inj.). Its marketed products had revenues of $150 million in 2016 (source). The stock has shown a gain on unusual volume recently and we decided to look at this company.
Generic drugmaker Virtus Pharmaceuticals recently asked the FDA in a Citizens Petition to hold up on its plan to remove unapproved generic versions of potassium chloride from the market. Now it has filed a lawsuit demanding the FDA put on the brakes.
After several knockbacks, Merck & Co has finally moved a key step closer to securing FDA approval for its muscle relaxant reversal agent Bridion.
Reducing The Number Of Unapproved Drugs While Working To Prevent Drug Shortages: A Job That Calls For Strong Collaboration In FDA