LYCOS RETRIEVER 
Premarin
built 202 days ago
Premarin was the first hormone replacement therapy (HRT) drug to hit the market. Premarin was first marketed in 1942 to alleviate the symptoms of menopause in women. Today, Premarin is still the most popular HRT drug, and is one of the most prescribed drugs in the world. There are approximately 11 million women currently take Premarin. The popularity of this drug is due both to its extensive history and an aggressive marketing campaign by Wyeth.
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The major forms of estrogen in Premarin are estrone (>50%), equilin (15-25%) and equilenin. The estrogens in Premarin are often called "conjugated equine estrogens" (CEE) because the estrogen molecules are generally present with hydrophilic side-groups attached such as sulfate. Thus, estrone sulfate is actually the major molecule in Premarin. Estrone sulfate is easily absorbed into the blood after Premarin pills are taken by women. Estrone sulfate is converted to estradiol, an active estrogen normally found in women. It is not clear if estrogens such as equilin that are foreign to the human body have effects in women that are significantly different from the estrogens like estradiol that are normally made in the human body.
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No matter that the FDA had decided twice before that Premarin had only two active ingredients, both of which were already contained in Duramed's and Barr's generic product. In order to protect itself from further pressure, the FDA shifted course. It proposed to hold an advisory committee meeting made up of experts on estrogens and osteoporosis to review new information and invited Wyeth to provide data to substantiate its claims. These experts were to consider whether the USPC guidelines for conjugated estrogens needed revision based on new data and whether to upgrade delta 8,9 from an impurity to an active ingredient. Regardless of the outcome, Wyeth would get at least another 12-18 months with no generic competition.
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Prempro like Premarin is a medication commonly prescribed for patients in need of Hormone replacement therapy. The drug, which falls within a category of drugs knownas progestins, contains conjugated estrogens and medroxyprogesterone acetate. Approximately three million women in the United States take Premarin and Prempro daily to replace hormones lost at menopause as a means for reducing incidence of post- menopausal symptoms such as hot flashes, night sweats and vaginal dryness. The drug first received FDA approval as a hormone replacement therapy in 1995.
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The politics of Premarin cast a long shadow over Washington. Political considerations are apparently now front and center in the daily determinations of the FDA. A generic version of Premarin would save American women, many of whom are on fixed incomes and must take Premarin for life, hundreds of millions of dollars a year. Similarly, Medicaid and Medicare could save money in two ways. First, a generic version of Premarin would be less expensive. Second, lower prescription costs would allow more women to stay on the medication... avoiding the hip fractures and infirmities that cost millions more to treat.
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Premarin is produced at Wyeth-Ayerst in Brandon, Manitoba, Canada. This is known in the horse world as the "PMU capitol of the world." Urine is extracted from mares on about 50 different PMU farms in Canada. It is then shipped to a processing plant in Brandon. Wyeth sets the quotas, pricing and picks the farms as farmers compete to get the contracts from Wyeth that will set them up as PMU farms. Wyeth ... has a farm in Carnberry, which is operated like a working PMU farm. The security there is very tight because the work and experiments are strictly confidential.
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Premarin