Approximately 75% of menopausal women experience such symptoms as vaginal dryness and temperature fluctuations (“hot flushes”). Many women who have taken estrogen tablets or patches still experience vaginal symptoms. The FDA has approved an estradiol acetate vaginal ring (Femring™, Galen), the first vaginal estrogen product that is indicated to treat both the hot flushes and the vaginal symptoms associated with menopause. Galen plans to introduce the drug into the U.S. market in June 2003.

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The worldwide market for prescription drugs for women’s health is projected to almost double through the year 2007, according to new data released by Kalo-rama Information in New York City. Manufacturers’ revenues for the year 2002 approached $36 billion and are expected to be almost $64 billion by the year 2008.

The report reveals that the market has been growing at nearly 17% over the past five years, and it is predicted that growth will continue to be in the double digits for the foreseeable future. Growth will be supported by the aging of women around the world, particularly in the U.S., and an increase in product demand, spurred by a still growing women’s health-awareness movement, should expand the total market significantly.
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The study covers the products and markets for prescription drugs in all sectors of women’s health, such as autoimmune diseases, cancer, gynecological infections and sexually transmitted diseases, hormone-related indications (including menopause, contraception, and sexual dysfunction), osteoporosis, and urinary bladder disorders. The comprehensive report provides market size and growth projections, competitive market share, and epidemiological and clinical trends for a wide range of conditions, from breast cancer to yeast infections.

The FDA has granted marketing approval for a new generic estradiol/levonor-gestrel transdermal (skin patch) system (Climara Pro®) for the treatment of menopausal symptoms. This thin, translucent patch is the first once-weekly combined hormone therapy approved in the U.S. Schering’s U.S. subsidiary, Berlex, Inc., plans to launch Climara Pro® in January 2004.

The transdermal (patch) technology allows for a continuous delivery of hormones at doses much lower than those in pills. Easily affixed to the skin, Climara Pro® delivers 0.015 mg/day of levo-norgestrel and 0.045 mg/day of estra-diol. Estradiol canadian is the most active estrogen made by the ovary. This therapy is approved for the relief of moderate to severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats.

Climara®, Schering’s once-weekly estrogen-only patch, is appropriate for women who have had a hysterectomy. With the addition of drug levonorgestrel, Climara Pro® is indicated for women with an intact uterus.

The FDA has approved a new oral contraceptive (Seasonale®, Barr Laboratories) for women. Seasonale® contains a progestin (levonorgestrel) and an estrogen (ethinyl estradiol), which are active ingredients in traditional oral contraceptives.

Seasonale® offers a 91-day regimen. Tablets containing the active hormones are taken for 12 weeks (84 days), followed by one week (seven days) of placebo (inactive) tablets. Conventional oral contraceptive use is based on a 28-day regimen (21 days of active tablets, followed by seven days of placebo tablets).

Under the new dosing regimen, the number of expected menstrual periods usually experienced by women is reduced from once a month to about once every three months. As with the conventional 28-day regimen, women have a menstrual period while taking the placebo tablets.

Although Seasonale® users have fewer scheduled menstrual cycles, many women, especially in the first few cycles of use, had more unplanned bleeding and spotting between the expected menstrual periods than women taking a conventional 28-day cycle oral contraceptive.

Some physicians have raised concerns about the consequences of long-term suppression of menstruation, suggesting that data are insufficient to prove that suppression is safe. They also noted that the women in the studies were already taking oral contraceptives and thus would “automatically” be able to tolerate the medication; they were not compared with a control group of women who were not taking oral contraceptives. The supporters of menstrual suppression argue that ovulation itself can inflame the lining of the ovary and might be linked to ovarian cancer. The debate, no doubt, will rage on.

Because Seasonale® users can expect to have fewer periods, the label also advises women to consider the possibility that they might be pregnant if they miss any scheduled periods.

The FDA has approved updated labeling for Ortho-McNeil’s contraceptive patch, Ortho Evra^®, to warn health care providers and patients that this product exposes women to higher levels ofestrogen than most oral contraceptives. Ortho Evra^® was the first skin patch approved for birth control.

The patch releases the estrogen hormone ethinyl estradiol and the drug progestin hormone norelgestromin through the skin into the bloodstream.

Women taking this product should consult their health care providers to balance the potential risks related to increased estrogen exposure against the risk of pregnancy if they do not follow the daily regimen associated with typical birth control pills. Because the patch is changed once a week, it decreases the chance that one or more daily doses might be missed, as may occur with birth control pills.

The new bolded warning states that users of the product are exposed to about 60% more estrogen than if they were taking a typical birth control tablet containing 35 mcg of estrogen. However, the maximum amount of estrogen to which women are exposed is about 25% lower with Ortho Evra® than with the tablets.

The FDA is continuing to monitor safety reports for problems with the patch.

The FDA has approved the NDA for Seasonique (canadian levonorgestrel/ethinyl estradiol 0.15 mg/0.03 mg and ethinyl estradiol 0.01 mg) tablets (Barr Phar-maceuticals/Duramed) to prevent pregnancy. Seasonale, Barr’s earlier extended-cycle oral contraceptive, was launched in 2003 as a 91-day regimen. Tablets containing the active hormones are taken for 12 weeks (84 days), followed by seven days of placebo (inactive) tablets, thus offering the convenience of just four menstrual periods per year.

Seasonique provides continuous hormonal support in the form of a low dose of estrogen in place of seven placebo tablets taken during the month. Patients take the active tablets for 84 consecutive days, followed by seven days of 0.01 mg of ethinyl estradiol. The regimen is also designed to reduce the number of withdrawal bleeding periods to four times per year.

Barr received an approvable letter for Seasonique in August 2005. In March 2006, the FDA determined that no additional clinical studies would be required to support the approval.

Wyeth’s Lybrel, the first continuous-use oral contraceptive, has been approved. The tablet comes in a 28-day pack with low-dose combination tablets containing 90 mcg of a progestin (generic levo­norgestrel) and 20 mcg of an estrogen (ethinyl estradiol).

With the traditional contraceptives, patients take the medication for 21 days, then stop for seven days; the placebo or pill-free time intervals last four to seven days to simulate a menstrual cycle. The Lybrel regimen does not include the week off from the placebo tablets.

Women who use Lybrel do not have a scheduled menstrual period but may experience unplanned breakthrough bleeding or spotting; this effect usually tapers off within the first year of use.

The safety and efficacy of Lybrel as a contraceptive method were supported by two one-year clinical studies enrolling more than 2,400 women 18 to 49 years of age.