Mallinckrodt Xartemis XR Launch Delayed by FDA

[Anonymous]

Here's a New York Times article about it: http://markets.on.nytimes.com/resea...RX____BW5348&feedID=600&press_symbol=58839194

It states: "The three-month extension from the FDA is in response to additional data submitted by Mallinckrodt. Mallinckrodt and the FDA have begun and will continue discussions regarding labeling as part of the application review throughout this period."

Basically, it's just a labeling issue.

The FDA probably did not grant an "abuse deterrent" label. This would be extremely important when entering a market that is loaded with generics. This is the only thing I can think of that would delay due to "labeling". The indication was pretty straight forward for this medication.

 

[Anonymous]

Good luck to all! If anyone can give some advice, I had phone interview, idk what I did not to get f2f. I asked for feedback got nothing. Thought I did well, what were they looking for?? Thanks. I have pharma experience over 10 years

You dodged a major bullet!!