Last-minute 2006 US FDA decisions end with mostly "approvable" letters

Although, historically, the US Food and Drug Administration has made a lot of drug approval decisions in the last few days before a year end, 2006 was a little different in that the last moment rulings were mostly in the form of "approvable" letters, meaning that full clearance was dependent on additional action from the company concerned.

Vyvanse gets 2nd approvable letter

UK-based drugmaker Shire and its US partner New River Pharmaceuticals said they have been issued with a second FDA approvable letter regarding their co-developed attention-deficit hyperactivity disorder treatment Vyvanse (lisdexamfetamine dimesylate). The new document does not request that any new trials are conducted, but does ask for additional data, which the firms describe as routine and not expected to delay the launch of the product, scheduled for the second quarter of the year.