We ordered Deflazacort for our son nearly a month ago from Masters in the UK and hadn't received it. Got a letter today from the US FDA at the Los Angeles Port of Entry saying the shipment is being detained and is "subject to refusal of admission into the US due to it being an unapproved new drug."
They give the following link as an explanation and a list of exceptions:
FDA, however, has a policy explaining that it typically does not object to personal imports of drugs that FDA has not approved under certain circumstances, including the following situation:
Seems like we meet most of the exceptions.
Anyone else had this happen yet? They give instructions on how to appeal, so I'll post back with the results.
Have not had any issues and we just received a shipment in April. I thought I also read in the recent edition of Quest Magazine (MDA) that they are trying to fast track deflazacort for approval in the US. (I don't think I read that incorrectly, but will double check).
Was finally able to reach someone at the FDA and had to provide a letter from our neurologist stating the condition and why we needed the medicine. Also needed to send them the Rx before they would release it. Still haven't gotten it though.
please can you tell me from where did you order the deflazacort??? as i m in Egypt and i need to get for my son urgently.
We purchase Deflazacort from Masters Pharmaceuticals. The company is located in England.
Here is the website: http://www.masters-uk.com/medicines/home.php
The international phone number is 011) 44.208.327.3169 / (011) 44.208.327.0900
My family and I have prayed that your son will receive this necessary drug as soon as possible. God speed as you continue to travel this journey.
thank you so much sir
Thanks Susan! We had looked into that program and brought it up to our neuromuscular doc (at Cincinnati Children's Hospital in Cincinnati, Ohio). She is not recommending it to her patients, for various reasons. From what my husband and I understand from PPMD and the MDA, Deflazacort is due to become FDA approved within the next year.