|
| |
Current Status of EPD
The manufacturer of EPD (McEwen Laboratories, LTD, England) is in the process of
submission of an IND (investigational new drug) application to the FDA in an
attempt to obtain FDA approval. (Note: The American EPD Study was conducted
before the manufacturer began the IND submission process.) The FDA banned EPD
immunotherapy in the United States in April of 2002, pending approval of the
drug, and placed EPD on their Import Alert List. Until early in 2004, the FDA
was allowing some personal importation of EPD by patients, but importation has
now been severely restricted and EPD is no longer available under any
circumstance in the USA. EPD is used in Canada, Europe and several other
countries outside the E.U.
It is very highly unlikely that EPD or LDA will ever receive
FDA approval. The costs of FDA approval (the average cost of the
average drug approved today is about 800 million dollars) are simply too great
to allow either to be a financially viable treatment, even if they were
approved. Further, the number of allergens contained in EPD and LDA is far
too great for the FDA to consider approval, since the FDA's approval slogan is
effectively, "one drug, one indication".
|
![[Company Logo Image]](images/logo.gif){kind=logo}
