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Planb | Plan B | Emergency
Contraception | Levonorgestrel |
Pregnancy
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Levonorgestrel
(or L-Norgestrel) is a molecule used in hormonal contraceptives
under the family of progestins. Also called PLANB.
FDA News
FOR IMMEDIATE RELEASE
P06-118
August 24, 2006
Media Inquiries:
Julie Zawisza, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older
Prescription Remains Required for Those 17 and Under
The U.S. Food and Drug Administration (FDA) today announced approval of
Plan B, a contraceptive drug, as an over-the-counter (OTC) option for
women aged 18 and older. Plan B is often referred to as emergency
contraception or the "morning after pill." It contains an ingredient
used in prescription birth control pills-only in the case of Plan B,
each pill contains a higher dose and the product has a different dosing
regimen. Like other birth control pills, Plan B has been available to
all women as a prescription drug. |
When used
as directed, Plan B effectively
and safely prevents pregnancy. Plan B
will remain available as a prescription-only
product for women age 17 and under.
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Duramed, a subsidiary of Barr
Pharmaceuticals, will make Plan B available with a rigorous labeling,
packaging, education, distribution and monitoring program. In the CARE
(Convenient Access, Responsible Education) program Duramed commits to:
Provide consumers and healthcare professionals with labeling and
education about the appropriate use of prescription and OTC Plan B,
including an informational toll-free number for questions about Plan B;
Ensure that distribution of Plan B will only be through licensed drug
wholesalers, retail operations with pharmacy services, and clinics with
licensed healthcare practitioners, and not through convenience stores or
other retail outlets where it could be made available to younger women
without a prescription;
Packaging designed to hold both OTC and prescription Plan B. Plan B will
be stocked by pharmacies behind the counter because it cannot be
dispensed without a prescription or proof of age; and
Monitor the effectiveness of the age restriction and the safe
distribution of OTC Plan B to consumers 18 and above and prescription
Plan B to women under 18.
Today's action concludes an extensive process that included obtaining
expert advice from a joint meeting of two FDA advisory committees and
providing an opportunity for public comment on issues regarding the
scientific and policy questions associated with the application to
switch Plan B to OTC use. Duramed's application raised novel issues
regarding simultaneously marketing both prescription and
non-prescription Plan B for emergency contraception, but for different
populations, in a single package.
The agency remains committed to a careful and rigorous scientific
process for resolving novel issues in order to fulfill its
responsibility to protect the health of all Americans.
For more information on Plan B and today's action, please see:
http://www.fda.gov/cder/drug/infopage/planB/default.htm .
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Source: Press Releases - Wikipedia, FTC and
other public domain sources and product web sites. We have no
affiliation with any of them.
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Planb | Plan B | Emergency
Contraception | Levonorgestrel
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