-Plan B One-Step® will be the First
Emergency Contraceptive to be in Store Aisles-
NORTH WALES, Pa.--(BUSINESS WIRE)--Jun. 21, 2013--
Teva Women’s Health, a subsidiary of Teva Pharmaceutical Industries Ltd.
(NYSE: TEVA) announced today that the U.S. Food and Drug Administration
(FDA) has approved the emergency contraceptive Plan B One-Step® (levonorgestrel)
tablet 1.5 mg for over-the-counter sale to all consumers in the United
States. This landmark decision represents the continuation of improving
access to emergency contraception to all who need it, when they need it.
Plan B One-Step® is the first one pill emergency
contraceptive that will be available in store aisles with no age or
point-of-sale restrictions, and will not require consumers to show
identification in order to purchase it.
“Bringing Plan B One-Step® out from behind the pharmacy
counter helps women tremendously by removing one of the biggest barriers
to access and timely use of emergency contraception, which is critically
important. Plan B One-Step® allows women to get what they
need with one dose, without waiting 12 hours to take a second pill to
complete the regimen,” said Jill DeSimone, Senior Vice President &
General Manager, Teva Global Women's Health. “We are committed to
ensuring Plan B One-Step® is available to women who need it
as it transitions into the aisle. As such, the price of Plan B One-Step®
to wholesale and retail outlets will remain unchanged. Plan B One-Step®
will also continue to be sold to hospitals and health clinics at a
subsidized price for women who may not otherwise be able to afford it.”
“At Teva we are committed to ensuring information, educational tools and
healthcare professional support are made available to all those who need
it, right at the time that they need it,” continued DeSimone. “These
offerings make us a true partner for women as they manage their health
through their reproductive years.”
In the U.S., the unintended pregnancy rate remains high; nearly half
(49%) of all pregnancies are unplanned. The fact that nearly half of the
3.1 million unintended pregnancies that occur in the U.S. each year
occur in women who reported taking contraception during the month they
conceived emphasizes the need for increased access to emergency
contraception. With Plan B One-Step®, women can
take an additional step to prevent an unintended pregnancy after
contraceptive failure or unprotected sex.
“Teva, as well as women’s health advocates and leading medical
professionals, has worked for years to increase access to this
time-sensitive product that is critically important to all women of
reproductive age,” said Martin Berndt, Vice President & General Manager,
U.S. Brand Pharmaceuticals, Teva Women’s Health, Inc. “As is customary
for any prescription to full over-the-counter switch, and as requested
by the FDA, Teva completed a clinical study to support non-prescription
marketing of Plan B One-Step®. Teva is the only company that
has conducted actual use and label comprehension studies required by the
FDA, which show that women of all ages understand how to use Plan B
One-Step®.”
Consumers can learn more about Plan B One-Step® by visiting www.PlanBOneStep.com,
where they can get reliable information about the product and when it
should be taken, and review answers to frequently asked questions. There
is also a toll-free hotline (1-800-330-1271) where consumers can talk
live to a healthcare professional.
About Plan B One-Step®
Plan B One-Step® is a progestin-only emergency contraceptive
that can help prevent pregnancy after birth control failure or
unprotected sex. When taken within 72 hours (three days) after birth
control failure or unprotected sex, Plan B One-Step® can help
prevent a pregnancy from occurring in about seven of eight women who
would have become pregnant otherwise. Plan B One-Step® is not
an abortifacient and will not harm an existing pregnancy. Plan B One-Step®
is a back-up method of preventing pregnancy, but it isn’t regular birth
control and should not be used that way, as it is not as effective as
regular birth control methods used correctly. For additional
information, visit www.PlanBOneStep.com.
Plan B One-Step® (levonorgestrel) is intended to prevent
pregnancy after known or suspected birth control failure or unprotected
sex.
About Teva Women’s Health, Inc.
Teva Women’s Health, Inc. is a U.S.-based subsidiary of Teva
Pharmaceutical Industries Ltd. (NYSE: TEVA), headquartered in Israel.
The company produces a wide range of women’s healthcare products
including oral contraceptives, intrauterine contraception and hormone
therapy treatments for menopause and perimenopause. Teva Women’s Health,
Inc. maintains a strong commitment to enhancing women’s lives by
actively pursuing new areas of research and providing distinct
pharmaceutical options that meet women’s needs and fit their lifestyles.
Through close engagement with women and healthcare providers, the
company maintains an in-depth understanding of the important health
matters that affect women.
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which express the
current beliefs and expectations of management. Such statements are
based on management’s current beliefs and expectations and involve a
number of known and unknown risks and uncertainties that could cause our
future results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products,
competition for our innovative products, especially Copaxone® (including
competition from innovative orally-administered alternatives, as well as
from potential purported generic equivalents), competition for our
generic products (including from other pharmaceutical companies and as a
result of increased governmental pricing pressures), competition for our
specialty pharmaceutical businesses, our ability to achieve expected
results through our innovative R&D efforts, the effectiveness of our
patents and other protections for innovative products, decreasing
opportunities to obtain U.S. market exclusivity for significant new
generic products, our ability to identify, consummate and successfully
integrate acquisitions, the effects of increased leverage as a result of
recent acquisitions, the extent to which any manufacturing or quality
control problems damage our reputation for high quality production and
require costly remediation, our potential exposure to product liability
claims to the extent not covered by insurance, increased government
scrutiny in both the U.S. and Europe of our agreements with brand
companies, potential liability for sales of generic products prior to a
final resolution of outstanding patent litigation, our exposure to
currency fluctuations and restrictions as well as credit risks, the
effects of reforms in healthcare regulation and pharmaceutical pricing
and reimbursement, any failures to comply with complex Medicare and
Medicaid reporting and payment obligations, governmental investigations
into sales and marketing practices (particularly for our specialty
pharmaceutical products), uncertainties surrounding the legislative and
regulatory pathways for the registration and approval of
biotechnology-based products, adverse effects of political or economical
instability, corruption, major hostilities or acts of terrorism on our
significant worldwide operations, interruptions in our supply chain or
problems with our information technology systems that adversely affect
our complex manufacturing processes, any failure to retain key personnel
or to attract additional executive and managerial talent, the impact of
continuing consolidation of our distributors and customers, variations
in patent laws that may adversely affect our ability to manufacture our
products in the most efficient manner, potentially significant
impairments of intangible assets and goodwill, potential increases in
tax liabilities, the termination or expiration of governmental programs
or tax benefits, environmental risks and other factors that are
discussed in our Annual Report on Form 20-F for the year ended December
31, 2012 and in our other filings with the U.S. Securities and Exchange
Commission. Forward-looking statements speak only as of the date on
which they are made and the Company undertakes no obligation to update
or revise any forward-looking statement, whether as a result of new
information, future events or otherwise.
Plan B One-Step® is a registered trademark of Women’s Capital
Corporation, a subsidiary of Teva.
© 2013 Teva Women’s Health, Inc.
Source: Teva Pharmaceutical Industries Ltd.
Media Contact:
Teva Pharmaceutical Industries Ltd.
Denise
Bradley, 215-591-8974
denise.bradley@tevapharm.com