Eleanor Kellon, VMD
--- In EquineCushings@..., "millionairess1989" <millionairess1989@...> wrote:
Do you have any more details, press release, etc.?
Pharmacies are regulated by the states so there is no such thing as an FDA approved pharmacy.
FDA may have given them permission to market it for equine use, or BI may have applied for a new animal drug application to get FDA approval.
If they have FDA approval as a new animal drug, it will be illegal to compound pergolide from bulk drug. They would have to compound from Prascend, which would make it more expensive than the Prascend itself. However, there have been some court decisions upholding animal compounding from bulk drugs so the issue may eventually make it to the courts.
If they only have approval to sell without actual FDA approval of the drug, similar to the current situation with compounded drugs being allowed, they will not have any more legal status and you should still be able to choose compounded.
No official statements from BI or FDA so that's all I can say for now. Elanco also had pergolide under study for equine PPID use at three US universities but no official word on that yet either.
Eleanor in PA