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.