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Month: December 2016

Minivelle Vivelle Shortages Explained

Minivelle Vivelle Shortages Explained

Minivelle and Vivelle continue to be in short supply in most pharmacies across the country.  Initially, I was not able to determine any reason. Nothing revealed by simple Google searches.  No FDA drug recalls.  Not evident from FDA drug shortage surveillance lists.

Now, one of my astute and persistent patients was able to track down the reason.   The FDA has been very critical of testing and quality assurance methods for this product.  Adherence to CGMP.  Current Good Manufacturing Practices.  The reasons seem sound but are not technically safety related.

Here is the full FDA warning letter which is long and tedious.  It is illuminating for you.

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Minivelle Vivelle Short Supply

Minivelle Vivelle Short Supply

Minivelle 17 beta estradiol system

Minivelle and Vivelle are severely backordered. We have not been able to determine the source of this short supply. It emanates from the manufacturer. This is not a local pharmacy problem it is not a distribution problem. For obscure reasons it is not being manufactured. We have not seen any recalls.

The 0.1 mg dose is in most demand and in short supply. Many of you have been dispensed a generic form of estradiol patches. Mylan is the leading generic house. Generic patches are not the same as the proprietary drug — Minivelle or Vivelle dot.

Estrogen patches are not about the drug which is bioidentical. It is 17-beta-estradiol. That is bioidentical.  Biologically identical to your own internally produced hormones.  The FDA prohibits the manufacturer labeling this as bioidentical.    That is a legal-political issue.  Not a medical issue.

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