Denied an application for a generic Premarin
The FDA has denied an application for a generic Premarin.
This is because Premarin is made from pregnant mares' urine...and contains at least 10 different estrogens. The proposed generic is synthetic...and doesn't contain all these estrogens.
There has been lots of debate about whether the minor estrogenic ingredients are "impurities"...or whether they contribute to Premarin's effectiveness.