FDA review process-guanfacine | ADHD Information

Does anybody know how the FDA review process works? Shire submitted guanfacine XR back in August 2006 and they said it was subject to a 10 month review. Well, it's been almost exactly 10 months. Does the FDA have to give a response within the time frame? I think all the studies regarding the drug have been favorable. I am anxious to try this with my dd but her dr. wants to wait for approval. Thanks so much!!!!!!!!!!!!!!!!!!!!!!It's not a bad idea to wait for approval. It will be a different med than Guanfacine, different delivery form called Connexyn (I believe). It will be a long acting med.

The process usually includes questions from the FDA that have to be answered, an inspection of the manufacturing site (should be a no brainer because they make other approved meds), a meeting of a small committee that will recommend for or against approval. Then the FDA will make the final decision. The first public information that should come out is the committee recommendation about approval.

At this time the only way to get the med is to be part of the clinical trial they are doing for ADHD plus ODD.