Pharma Blog Watch

Approvable Letters on the Rise? (Eye on FDA)
In his blog, Mark Senak discusses the topic of FDA approvable letters. "There has been a recent current of thought … that the category of approvable letters has grown in recent months in order for the agency to have issued an 'action' by time the [Prescription Drug User Fee Act] date has come merely because they are unable to keep up with solid decisions of yes or no by the action date," he writes.

"To that end, this past week Shire received an approvable letter for the attention deficit treatment NRP-104, with the agency saying that the company needed to work on details including labeling information, scheduling and the drug's trade name," he points out, adding that sometimes "[t]he contingencies noted by the FDA can be very easy to accomplish (as in Shire's case). …"