Danco Laboratories
Company News
Mifepristone was developed in France and was approved for use there in September
1988. In 1991, it was approved by the United Kingdom Licensing Authority
for use in Great Britain, and in 1992, it was approved for use in Sweden.
In May 1994, Department of Health and Human Services Secretary Donna
Shalala announced that as a result of encouragement by the Clinton administration,
the U.S. rights for mifepristone had been donated to the Population Council,
a New York-based nonprofit research institution. The Population Council
conducted U.S. clinical trials from 1994-1995. Results of the Population
Council clinical trials, showing mifepristone followed by misoprostol
to be highly safe and effective, and acceptable for ending early pregnancy,
were published in the New England Journal of Medicine and the Archives
of Family Medicine in 1998.
Following public hearings on the subject, the FDA Advisory Committee
for Reproductive Health Drugs recommended approval of mifepristone in
the summer of 1996. In September 1996, the FDA issued an approvable letter
for mifepristone indicating that the drug was safe and effective, but
that the Population Council needed to provide additional manufacturing,
labeling, and other information in order to obtain final approval.
The Population Council granted us -- Danco Laboratories -- an exclusive
license to manufacture, market, and distribute Mifeprex in the United
States. Danco Laboratories is a women's health pharmaceutical company,
responsible for all aspects of the introduction of Mifeprex in the United
States, including manufacturing, distribution, marketing, promotion, training,
and FDA compliance. After having satisfied the FDA requirements, Danco
Laboratories received final FDA approval to manufacture and distribute
Mifeprex in the U.S. in September 2000.
In the first 3 years since U.S. approval, Mifeprex has been used by over
200,000 women in the U.S. Mifepristone has been used worldwide by more
than 1 million women and has now been approved in 29 countries, including
major European countries and the U.S.
You can reach the Mifeprex hotline by calling 1 (877) 4-Early Option or
1 (877) 432-7596 or by emailing info@earlyoption.com
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