Message Number: FHL12229 | New FHL Archives Search
From: ""
Date: 2010-09-17 04:11:20 UTC
Subject: [ferrethealth] Re: Any FDA okayed Leuprolide Acetate depot AS THE GENERIC?

[Again, nothing indicates that this is the time release
form rather than the daily form of this SAME compound.

The FDA DOES retain the right to seize any imported
drugs that are the same as an existing U.S. drug SOLELY
because it is the same. Of course, they can seize for
other reasons, too. I learned that in direct conversations
with an FDA official years ago when I was helping a
family whose child needs an "orphan drug which was
in short supply in regular pharmacies. Their answer
for their human child actually turned out to be to use
the FHL's Compounding Pharmacy List because the
drug is more often used for veterinary needs, so finding
compounding pharmacies that help both animals and
people allowed their daughter to the be treated. That
list can be found in the FHL Files section.

-- Moderator]

> [The question is NOT if there is generic Lupron.
> That drug has been around long enough for
> generics.
> The question is if there is an FDA approved
> rather than the daily form of Lupron, and
> that is an entirely different question.
> -- Moderator]

And the answer is yes.

Listing of manufacturers of FDA "ANDA" (see below) approved Leuprolide Acetate....

ANDA explained:

Abbreviated New Drug Application (ANDA)

An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.

Generic alternatives, with FDA approval, are indeed available. And as I attempted to point out in my previous post, but apparently failed to do, the company that manufactures Lupride (which I've been using in my ferrets for near two years) is FDA approved to do so.

Karen McCabe


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