This has to be good news for us, a qualified trial in horses that has led to FDA approval.
Stack that up with dogs and humans on our side......
I did find these comments a bit interesting and slightly humorous :
HUMAN FOOD SAFETY
"The product labeling contains the following Warning statement: Do not use in horses intended for human consumption."
Exclusivity
Zycosan™, as approved in our approval letter, qualifies for FIVE years of
marketing exclusivity beginning as of the date of our approval letter. This drug
qualifies for exclusivity under section 512(c)(2)(F)(i) of the FD&C Act because
this is the first time we are approving this active moiety in a new animal drug
application submitted under section 512(b)(1) of the FD&C Act.
C. Patent Information
For current information on patents, see the Green Book Reports in the Animal
Drugs @ FDA database.
USER SAFETY
The product labeling contains the following information regarding safety to humans
handling, administering, or exposed to Zycosan™:
Not for use in humans. Keep out of reach of children. Pentosan polysulfate sodium is
a weak anticoagulant. Caution should be used when administering Zycosan™ if you
are taking an anticoagulant. In case of accidental self-injection, seek
immediate medical attention. If product comes into contact with skin, rinse
skin thoroughly with water and seek medical attention if needed. To obtain a
Safety Data Sheet (SDS), contact Dechra at (866) 933-2472.
All good - ours is ok for self-injection
https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/13249
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This has to be good news for us, a qualified trial in horses...
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