September 24, 2002 | November 16, 2000 | September 28, 2000
September 24, 2002
MORE THAN 100,000 U.S. WOMEN HAVE CHOSEN MIFEPREX FOR THEIR NON-SURGICAL
ABORTION
Danco Laboratories releases use data for Mifeprex® (Mifepristone), Tablets 200 mg
New York, NY – Today, Danco Laboratories reports that more than 100,000 U.S. women have used Mifeprex*, the early option pill, since FDA approval in September 2000 and product availability in November 2000. Sales in the United States are 36 percent higher for the first eight months of this year compared to last year, indicating increased use of Mifeprex by American women. Nearly one million women worldwide, excluding China, have used mifepristone over the last decade. Mifepristone is now approved in 26 countries including major European countries and the United States.
Taken orally, the early option pill provides women with a non-surgical method for early abortion, up to seven weeks after the beginning of their last menstrual period. Mifeprex offers women the freedom to make the best decisions for themselves and their families.
Where can Women get Mifeprex?
Mifeprex is available in almost every state and from a variety of health
care providers.
• Current sales information reveals that clinics, such as those affiliated
with Planned Parenthood Federation of America and National Abortion Federation
(NAF) as well as independent clinics represent 83 percent of Mifeprex
sales. Private practices represent 17 percent of sales. At launch, virtually
all sales and use of Mifeprex were in clinics.
• Current account information reveals that clinics represent 37 percent
of accounts, while private practices represent 63 percent.
• Physicians in 47 states, the District of Columbia, Guam and Puerto
Rico offer Mifeprex to their patients.
Where can Women get Information about Mifeprex?
• http://www.earlyoptionpill.com - The Mifeprex website has been
a source of information for women and health care providers throughout
the year. Not only can women use this site to access information and provider
referrals, but providers can learn more about the product, how to prescribe
it, and how to order it.
• 1-877-4 Early Option (1-877-432-7596) – The toll free Mifeprex
hotline is also available for those seeking information. Providers can
have their medical questions answered by a physician with experience providing
Mifeprex, 24 hours a day/ 7 days a week. Prospective patients can access
information on Mifeprex and provider referrals.
“We’ve seen a steady increase in clinics and physicians providing this service to their patients over the last two years,” said Dr. Richard Hausknecht, Associate Clinical Professor of OB/GYN at Mt. Sinai School of Medicine and Medical Director of Danco Laboratories. “We are confident that this trend will continue, providing more American women with an early non-surgical option when it comes to their reproductive health.”
“As a family practitioner, I feel medical abortions are an important part of offering my patients the comprehensive care they may need,” said Dr. Ruth Lesnewski. “One of my goals as a physician is to help women avoid procedures they do not want to have if non-invasive alternatives are available.”
More Information about Mifeprex.
Mifeprex blocks a hormone that is needed for pregnancy to continue. When
followed by another medicine, misoprostol, Mifeprex ends the pregnancy.
Mifeprex followed by misoprostol is approximately 92–95 percent effective. Bleeding and cramping are a normal part of the process; women can expect bleeding or spotting for an average of 9–16 days. In the case of heavy bleeding, some women may require a surgical procedure. Side effects that may occur include nausea, headache, vomiting, diarrhea, dizziness, fatigue and back pain.
A woman makes three visits to a doctor’s office or clinic over a two-week period. During the first visit, she must read and sign a statement that she has decided to end her pregnancy. Health care providers will give their patients a number to call if they have any questions, and, a number to call if emergency care is needed.
Before Mifeprex received final FDA approval, every aspect of the drug regimen was rigorously tested and thoroughly reviewed. Over 2,000 women participated in clinical studies in the United States. The results were published in The New England Journal of Medicine and the American Medical Association’s Archives of Family Medicine.
Danco Laboratories, LLC is a women’s health pharmaceutical company that has been granted an exclusive license from the Population Council to manufacture, market and distribute Mifeprex in the United States.
For more information about Mifeprex, please access the Mifeprex web site
at
www.earlyoptionpill.com. Or call the Mifeprex hotline at 1-877-4 Early
Option (1-877-432-7596).
###
B-roll footage is available upon request.
High-resolution images of the product are available to download on the Mifeprex web site.
* Mifeprex is a registered trademark of Danco Laboratories, LLC.
November 16, 2000
DANCO LABORATORIES, LLC ANNOUNCES AVAILABILITY OF MIFEPREX™ (Mifepristone) Tablets, 200 mg
New York, NY – Danco Laboratories announced today the availability of Mifeprex* - the early option pill - a safe and effective non-surgical method for ending early pregnancy.
Shipments of Mifeprex to physicians begin on Monday, November 20, 2000. Danco is also sending informational materials to health care professionals.
“After having successfully used mifepristone in U.S. clinical trials, I am excited that Mifeprex has been approved by the FDA and is now available to women,” said Paul D. Blumenthal, MD, MPH, Associate Professor, Department of GYN/OB at Johns Hopkins University School of Medicine. “The availability of Mifeprex creates an important new set of choices for both women and their health care providers. I am enthusiastic about being able to offer Mifeprex to my patients and am certain it will help me to better meet their needs."
Health care providers interested in purchasing Mifeprex for their patients can do so by accessing http://www.earlyoptionpill.com or by calling the Mifeprex hotline at 1-877- 4 Early Option (1-877-432-7596).
Mifeprex is a medical breakthrough in the United States. Taken orally, the early option pill is non-invasive and, for most women, does not involve surgery or anesthesia. Mifeprex can be taken to end a pregnancy from the time a woman knows she is pregnant up to seven weeks after the beginning of her last menstrual period. A woman using this option makes three visits to a doctor’s office or clinic over a two-week period.
Mifeprex followed by misoprostol is approximately 92-95 percent effective for ending a pregnancy. Bleeding and cramping are a normal part of the process. Women may experience bleeding similar to or greater than a heavy period and can expect bleeding or spotting for an average of 9-16 days. In some cases, women may have severe bleeding and need to contact their doctor right away. Side effects that may occur include nausea, headache, vomiting, diarrhea, dizziness, fatigue and back pain. A few women who take Mifeprex will need a surgical procedure to end the pregnancy or to stop heavy bleeding. Health care providers will communicate to their patients how they have planned to handle this possibility and will give their patients a name and number to call if they have any questions and, if different, a name and number to call in an emergency.
More than 2,000 women participated in clinical studies in the United States. The results were published in The New England Journal of Medicine and the American Medical Association’s Archives of Family Medicine. Government regulatory agencies in France, Great Britain and Sweden approved mifepristone nearly a decade ago. More than half a million women in Europe have chosen this safe and effective early option. It has now been approved in eighteen countries worldwide.
“We’re pleased to bring Mifeprex to the U.S. marketplace,” said Heather O’Neill, Danco spokesperson. “Women can now finally access this important reproductive health option.”
Danco Laboratories, LLC is a women’s health pharmaceutical company that has been granted an exclusive license from the Population Council to manufacture, market and distribute Mifeprex in the United States.
Additional press materials are available via fax by calling 1-888-796-3683.
September 28, 2000
THE EARLY OPTION PILL FOR WOMEN
First FDA-Approved Non-Surgical Option To End Early Pregnancy
MIFEPREX™ (Mifepristone), Tablets 200 mg
For more information:
Pam Long, 206-332-1742
New York, NY - The Food and Drug Administration (FDA) today approved Mifeprex*,
a safe and effective non-surgical method for ending early pregnancy. Mifeprex
gives women an early option in pill form.
Mifeprex is a medical breakthrough in the United States. Taken orally, the early option pill is non-invasive and, for most women, does not involve surgery or anesthesia.
"It is an important day in women's health care. With FDA approval of Mifeprex, American women have a safe and effective early option for ending pregnancy," said Dr. Richard Hausknecht, Associate Clinical Professor of OB/GYN at Mt. Sinai School of Medicine and Medical Director of Danco Laboratories, LLC, the pharmaceutical company that brought Mifeprex to the United States. "We and our partners in the women's health community have worked long and hard for this day. I am excited and very proud to be part of this."
Mifeprex blocks a hormone that is needed for pregnancy to continue. When followed by another medicine, misoprostol, Mifeprex ends the pregnancy.
Mifeprex followed by misoprostol is approximately 92-95 percent effective for ending a pregnancy. Bleeding and cramping are a normal part of the process. Women may experience bleeding similar to or greater than a heavy period and can expect bleeding or spotting for an average of 9-16 days. In some cases, women may have severe bleeding and need to contact their doctor right away. Side effects that may occur include nausea, headache, vomiting and diarrhea. A pain reliever can be taken to alleviate discomfort.
Mifeprex can be taken to end a pregnancy from the time a woman knows she is pregnant up to seven weeks after the beginning of her last menstrual period. A woman using this option makes three visits to a doctor's office or clinic over a two-week period. At the first visit, she receives a Medication Guide (which explains how the early option works), is counseled and takes three tablets, each containing 200 milligrams of Mifeprex. Two days later she returns and takes two tablets, each containing 200 micrograms of misoprostol. A follow up visit approximately 12 days later checks that the pregnancy has ended. A few women who take Mifeprex will need a surgical procedure to end the pregnancy or to stop heavy bleeding. Health care providers will communicate to their patients how they have planned to handle this possibility. Health care providers will also give their patients a telephone number to call if they have any questions, concerns or problems.
"I think most women to whom I have given this treatment in a clinical trials setting found it very acceptable. It gave them more sense of control; they felt it was a more private approach to pregnancy termination," said Dr. Carolyn Westhoff, Professor of OB/GYN and Public Health at Columbia University. "One thing that is really important about Mifeprex is that it offers women the choice of an early approach to use. I think this is very valuable to women."
More than 2,000 women participated in clinical studies in the United States. The results were published in The New England Journal of Medicine and the American Medical Association's Archives of Family Medicine. Government regulatory agencies in France, Great Britain and Sweden approved mifepristone nearly a decade ago. More than half a million women in Europe have chosen this safe and effective early option. It has now been approved in eighteen countries worldwide.
Mifeprex is provided directly to doctors' offices or clinics and is not available through pharmacies. "As with any new reproductive health option, patient counseling and information is very important," said Dr. Richard Hausknecht. Mifeprex will be available to physicians in approximately 4 weeks.
"FDA approval of the drug mifepristone is an historical moment, comparable to the arrival of the birth control pill forty years ago," said Gloria Feldt, President of Planned Parenthood Federation of America. "We are overjoyed that with today's announcement from the FDA, Planned Parenthood will soon be able to offer American women the same early option that has been available in Europe for a decade."
Danco Laboratories, LLC is a women's health pharmaceutical company that has been granted an exclusive license from the Population Council to manufacture, market and distribute Mifeprex in the United States.
For more information about Mifeprex, please access the Mifeprex website
at
www.earlyoptionpill.com.
Or call the Mifeprex hotline at 1-877- 4 Early Option (1-877-432-7596).
Press materials are also available via fax by calling 1-888-796-3683.
High-resolution images of the product are available to download on the Mifeprex website.
* Mifeprex is a trademark of Danco Laboratories, LLC
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You can reach the Mifeprex hotline by calling 1 (877) 4-Early Option or
1 (877) 432-7596 or by emailing info@earlyoption.com