Letter from FDA

This topic has 5 replies, 4 voices, and was last updated 6 years, 11 months ago by nitro.

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27 November 2017 at 6:35 am #27055
HCV2B
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- Acolyte
@hcv2b
I was hoping to attach a letter I received from FDA.
It says this is an unapproved new drug without a new drug application. Personal importation policy requirements not met. Cosighnee is not an approved recipient of clinical trial shipments. It also names VELASOF as the drug. Is that another name for Epclusa?
(Sofosbuvir/Velpatasvir)
I am getting worried… plus they are asking for more money (DHA). For taxes or something.
27 November 2017 at 7:42 am #27056
Dr James
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- Guardian Angel
@fixhepc
Hello HCV2B, Jan will have been in touch.

You’re the second person we’ve seen get an FDA letter, which is a new thing.

So too is the notion of charging a tax. We see this randomly in the UK, but in the USA it’s only just started to happen.

YMMV
17 December 2017 at 6:46 am #27152
Lilyfield
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- Treatment Warrior
@lilyfield
This is surly a new wrinkle. I received Panovir (generic Epclusa) a year ago and had no problems. Were all the protocols followed?

I am going to see what I can find out.
18 December 2017 at 7:49 am #27155
Dr James
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- Guardian Angel
@fixhepc
Hi Lily, this wrinkle did get ironed out, but yes it is getting harder to ship to the USA.

New enthusiasm for administering rules, new hires, and a flying squad doing spot inspections.

For the last 2 years we have been periodically saying the window of opportunity may get slammed shut…

YMMV
18 December 2017 at 10:35 pm #27156
Lilyfield
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- Treatment Warrior
@lilyfield
Thank you Dr. James,

Yes, we were worried about this last year. Now, with a new administration, I’m being kind in my choice of words, it is even more important that people in the U.S. needing treatment, saddle up their ponies and ride!

Are ya’ all listening, U.S. hepC sufferers? This works. If I can be of help, give a holler.

Thank you, again Dr. J.
20 December 2017 at 7:14 am #27166
nitro
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- Novice
@nitro
OK…..i got the same letter…..just pay the duty fee…… its going to take i few days longer, but ull get it…i had this whole thing happen 4 weeks ago and i am now currently on the treatment and FEELIN GOOD….dont worry man…they are just tryin to scare you….Jan will help you ….shes GREAT at this…lol…..dont worry it will be in yours hand in now time…
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