Press Release
Plan B(R) OTC Now Available in Pharmacies Nationwide
New Education Program Launched for First and Only Dual-Label
Product
NEW YORK, Nov. 17, 2006 -- The new dual-label Plan B(R)
(levonorgestrel) emergency contraceptive arrives in
pharmacies this week. To help patients, pharmacists, and
healthcare providers understand how this unprecedented
product status - Rx and Over-the-Counter (OTC) - will work,
Duramed Pharmaceuticals, Inc., a subsidiary of Barr
Pharmaceuticals, Inc., will launch the CARE (Convenient
Access Responsible Education) Program, a comprehensive
education program for healthcare professionals and
consumers.
Approved on August 24, 2006, the new dual-label Plan B(R) is
an OTC product for consumers 18 years of age and older and
prescription only for women 17 and younger. It is marketed
as a single package, which allows for a prescription label
to be adhered to the package when dispensed to women age 17
and younger.
"We are pleased with the FDA's historic decision, which
gives women more timely access to Plan B(R) emergency
contraception," said Amy Niemann, Vice President of
Marketing-Proprietary Products at Duramed Pharmaceuticals,
Inc. "We are committed to educating consumers on the facts
about Plan B(R), as well as how they can purchase the
product depending on their age."
Over-the-Counter, but Behind-the-Counter
"For consumers 18 and older, Plan B(R) is available
over-the-counter, but it must be kept behind-the-counter,"
said Kathleen Besinque, PharmD., MSEd, FASHP, Associate
Professor of Clinical Pharmacy at USC School of Pharmacy,
Los Angeles, CA. "Consumers simply go straight to the
pharmacy counter, ask a pharmacy staff member for help, show
them a government issued ID, and get Plan B(R). Consumers
should read the enclosed patient information before taking
Plan B(R)."
Since some people may be embarrassed or afraid to ask the
pharmacist for emergency contraception, especially in a
crowded pharmacy, Besinque offers some tips for consumers to
help alleviate any concerns:
-- Hand the pharmacist a slip of paper with the request for
Plan B(R)
-- Ask to speak to the pharmacist privately in the
consultation area
-- Call the pharmacist to ask questions on the phone rather
than in person and tell them that you are coming in to
pick it up
For Women 17 and Younger
For women 17 and younger, Plan B(R) is still available with
a prescription from a healthcare provider. Another growing
option in some states where legislation has been passed and
regulations implemented is pharmacy access, which enables
women to get Plan B(R) directly from certified pharmacists
at participating pharmacies without going to a healthcare
provider first for a prescription. Nine states currently
have these programs in place, including Alaska, California,
Hawaii, New Mexico, Maine, Massachusetts, New Hampshire,
Vermont, and Washington.
Dispelling the Myths
Even after all the news, many women still are confused about
what Plan B(R) is, what it isn't, how to use it and now, how
to get it.
"Women need to understand that Plan B(R) is meant as a
backup contraceptive," said Tina Raine, MD, MPH, Associate
Professor of OB/GYN and Reproductive Sciences at UCSF, San
Francisco General Hospital. "Plan B(R) contains the same
safe hormone used in birth control pills, just in a higher
dose. Women also need to realize that it needs to be taken
as soon as possible after unprotected sex or contraceptive
failure."
How Plan B(R) Works
Consisting of two tablets of 0.75 mg levonorgestrel, Plan
B(R) works similar to other oral contraceptives - by
preventing ovulation or fertilization; it may also inhibit
implantation. Once implantation occurs, Plan B(R) is not
effective. Importantly, Plan B(R) will not work if a woman
is already pregnant. And there is no evidence that it will
harm a pregnant woman or a developing fetus.
Plan B(R) should be taken within three days (72 hours) of
intercourse, ideally within the first 24 hours after
unprotected sex. When taken as directed, Plan B(R) has been
shown to reduce the risk of pregnancy by up to 89 percent.
Important Information
Plan B(R) does not protect against the AIDS virus (HIV) or
other sexually transmitted infections. Common side effects
associated with the use of Plan B(R) included nausea,
abdominal pain, menstrual changes, dizziness, breast
tenderness, and vomiting. Please see full prescribing
information. For more information, please visit
http://www.go2planb.com or call 800-330-1271.
About Duramed Pharmaceuticals, Inc.
Duramed Pharmaceuticals, Inc., a subsidiary of Barr
Pharmaceuticals, Inc., focuses its product development and
marketing activities primarily in the women's healthcare
category. Since its formation in 2001, the Company's
proprietary products subsidiary has steadily grown to over
400 employees, including its Women's Healthcare and
Specialty Products Force. Duramed has 20 products in its
portfolio, primarily focused on women's healthcare products,
with particular emphasis on developing and marketing
products that serve the reproductive and menopausal needs of
women. During fiscal 2006, Duramed added five products to
its proprietary portfolio, including four women's healthcare
products. These include the SEASONIQUE(TM) extended-regimen
oral contraceptive; Mircette(R) oral contraceptive;
ENJUVIA(TM) hormone therapy; and the ParaGard(R) IUC.
Contact:
Sue Patton or Maren Smagala
Communications Strategies, Inc.
973-635-6669
Carol A. Cox
Barr Pharmaceuticals, Inc.
201-930-3720
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