Zaditen(R) (Ketotifen)



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FROM: Scott Theriault  
BCC: rmnrhodes@yahoo.com

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Monday, August 13, 2012 6:30 PM
TMS ANNOUNCEMENT
WEB UPDATE
Please let us know if you are experiencing any difficulty reading these emails.

Please read the announcement below about the drug Zaditen® (Ketotifen).


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Zaditen® (Ketotifen)

With much anticipation we are happy to announce that with the diligence of Kelli Foster our FDA/NORD representative patients with mast cell disorders can now order Ketotifen directly from the manufacturer, please read highlights below and ways to order!!!


BACKGROUND

For the last nine+ months, I have been tirelessly working to identify a safe, reliable and consistent source of Zaditen® (Ketotifen) for my daughter and myself. We have found that Zaditen® helps manage our Mastocytosis and Mast Cell Activation Disorder (MCAD) symptoms. Zaditen® is not available in the US. The only alternative we found was to have it compounded at a pharmacy. Due to personal preferences and concerns, I continued my investigation into procuring the brand name Zaditen® medication and expanded my search internationally. After a number of phone calls and emails between Novartis, Food and Drug Administration (FDA), and various international pharmaceutical companies, I was finally able to trace who "owned" Zaditen® (Ketotifen).


HIGHLIGHTS

Novartis transferred the license for Zaditen® (Ketotifen) Tablets 1mg and Elixir 1 mg/5 ml to Defiante Farmacêutica, S.A. (Defiante) in 2010.

Since 2010 Defiante Farmacêutica, S.A. holds the authorization to commercialize Zaditen® (Ketotifen) Tablets 1mg and Elixir 1 mg/5 ml in the United Kingdom (UK).

For commercial and logistic issues, Defiante Farmacêutica, S.A. signed a distribution agreement with Swedish Orphan Biovitrum Ltd. (SOBI).

In general, the distribution agreement states that Defiante supplies SOBI with Zaditen® and SOBI handles medication storage, supply, marketing and distribution activities within the UK.

Zaditen® (Ketotifen) 1mg tablets are manufactured with exactly the same quality, safety and efficacy profile as the Novartis supplied product. Defiante maintained the same composition, manufacturing method and specifications as Novartis.

The FDA has been very supportive and has guided me through the procedures that should be followed regarding the Personal Use Importation Policy of unavailable medications for patients under the care of a physician. Please keep in mind that the FDA does not promote the use of these products for off-label use but do understand that there are circumstances when a physician may believe under the practice of medicine that the products could be of benefit in certain patients. Nor does the FDA promote the use of a medication unapproved in the U.S. as this would be.

After many conversations with the FDA and because of the newly formed relationships between Defiante, SOBI and Masters Pharmaceuticals Ltd (a global specialty healthcare company with a heritage of over 25 years working with Manufacturers, Hospitals, Pharmacists, Governments and individual patients with the singular objective of 'Improving lives through patient access') brand name Zaditen® (Ketotifen) is available for Mastocytosis and Mast Cell Activation Disorder patients with a valid prescription through Personal Use Importation.


HOW TO ORDER

Secure a signed prescription for brand name Zaditen® (Ketotifen) from your physician.

Contact Julie at Masters Pharmaceuticals Ltd (1-800-969-1152) for product and shipping costs.

Fax the signed prescription for Zaditen® 1mg tablets to Masters Pharmaceuticals Ltd (1-800-969-1153 - Attention: Julie).

Provide appropriate payment (i.e. credit card, etc…) for prescription order.


WHAT TO EXPECT

Once Masters Pharmaceuticals Ltd has received your prescription and payment, they will prepare your prescription for International shipping.

NOTE: All international medication shipments are subject to the FDA Personal Use Importation Policy (see attachment) and US Customs Inspections. You should receive your three (3) month supply of brand name Zaditen® within approximately 10 business days.
The brand name Zaditen® (medication manufactured by Defiante Farmacêutica, S.A. distributed by Swedish Orphan Biovitrum Ltd. (SOBI))




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