So horse urine , like pig insulin, no longer have to be used because there are other drugs that can do the same thing. But the FDA did rule in 1997, that because of some ingredient factors the synthetics do not pass the identical active ingredients/efficacy test that is required under the federal Waxman-Hatch Act of 1984. But the FDA does admit that there is no conclusive proof that these factors effect anything in the drug Premarin. The FDA did finally approve the New Drug Application (NDA) of “Cenestin” on March 24th, 1999, which is a brand of plant based conjugated estrogen. The reason a NDA was filed was so it would be classified as a new drug and not a generic version of Permarin. But the alternative Permarin ended up being unsuccessful. This is probably because production of the PMU is good for Canadian economics. Most of the farms can be found in Manitoba, Alberta, and Saskatchewan, where there are little restrictions for the farms. The Premarin industry makes about 1.2 billion dollars annually for Wyeth-Ayerst Laboratories, the only pharmaceutical company that sells this product. A normal regimen can cost about $400 per year to maintain. Wyeth-Ayerst's has complete control over the Permarin industry, and even seems to have some influence with the FDA, which makes creating non-PMU drugs quite difficult even though they are unofficially effective (Premarin,
So horse urine , like pig insulin, no longer have to be used because there are other drugs that can do the same thing. But the FDA did rule in 1997, that because of some ingredient factors the synthetics do not pass the identical active ingredients/efficacy test that is required under the federal Waxman-Hatch Act of 1984. But the FDA does admit that there is no conclusive proof that these factors effect anything in the drug Premarin. The FDA did finally approve the New Drug Application (NDA) of “Cenestin” on March 24th, 1999, which is a brand of plant based conjugated estrogen. The reason a NDA was filed was so it would be classified as a new drug and not a generic version of Permarin. But the alternative Permarin ended up being unsuccessful. This is probably because production of the PMU is good for Canadian economics. Most of the farms can be found in Manitoba, Alberta, and Saskatchewan, where there are little restrictions for the farms. The Premarin industry makes about 1.2 billion dollars annually for Wyeth-Ayerst Laboratories, the only pharmaceutical company that sells this product. A normal regimen can cost about $400 per year to maintain. Wyeth-Ayerst's has complete control over the Permarin industry, and even seems to have some influence with the FDA, which makes creating non-PMU drugs quite difficult even though they are unofficially effective (Premarin,