[optimal] Re: manufacture of fluorescein
- From: stu weedn <stuweedn@xxxxxxxxx>
- To: optimal@xxxxxxxxxxxxx
- Date: Mon, 6 Feb 2012 11:26:37 -0800 (PST)
Dear fellow Optimal members,
I have tried to keep this discussion off Optimal to avoid any
misunderstandings and to prevent any panic buying. However in everyone's
interest I will try to respond to John's post .There are a couple of very
important points to keep in mind when reading the FDA action ( and I suggest
everyone should read it). First the FDA has given recognition (NDA & ANDA) to
Akorn and Alcon for going through the process of filing as recommended in
previous FDA guidance letters. Fluorescein as many of you know was
grandfathered into use through the Hatchman- Wax Act of 1984. The FDA has been
asking (as they should) for all manufacturers of grandfathered products to go
through the process of demonstrating that they have been found to be safe,
effective,of good quality and appropriately labeled. No manufacturers have been
found to be unsafe. HUB Pharmaceuticals must stop distribution of their
fluorescein inj. product by May 16. The product has not been found to be
unsafe and has been manufactured in it's current form for many years under
cGMP guidelines.
I have not been able to find anywhere outside of studies where Alcon has its
product in the market ( I would love to hear from anyone with different
information).
Alcon has approval for 10%. Akorn has approval for both 10% and 25% but at
this point does not have an NDC# for 25%.
In my professional opinnion this means that effective May 16 the only
fluorescein sodium for inj available for sale in the U.S. market will be Akorn
10%. All product from other manufacturers currently supplying fluorescein
sodium for inj may fall into this single source distribution channel, for at
least some period of time.
It is also my understanding that all product in the market from Altaire and HUB
will be fine for use until the labeled expiration date as long as the FDA
posted guidlines , in HUB's case no distribution after May 16, are followed.
If there are any questions please contact me offline by email or by phone for
more detailed information.
Financial interest!
Sincerely,
Stuart Weedn
President
Apollo Ophthalmics inc.
(c) 949-689-0293
(w)800-603-4164
apolloophthalmics.com
stuweedn@xxxxxxxxx
Stuart Weedn
Apollo Ophthalmics inc.
(c) 949-689-0293
(w)800-603-4164
apolloophthalmics.com
stuweedn@xxxxxxxxx
________________________________
From: "Head, John" <John_Head@xxxxxxxx>
To: optimal@xxxxxxxxxxxxx
Sent: Monday, February 6, 2012 9:08 AM
Subject: [optimal] manufacture of fluorescein
Hi all,
Thought I would share this…
A representative of a Fluorescein manufacturer came by our site with some news
about an action taken by the FDA.
I won’t summarize much, but here is a link to the FDA website.
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm280534.htm
apparently the FDA is looking closely at a couple manufacturers, and the FDA
have asked that they stop production, until further notice.
I have been told that Akorn, one of the manufacturers still approved, have
increased production, and will try to limit any possible shortages.
Best Regards,
John Head, CRA
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