FDA Approves New Drug Application (NDA) for Teva’s Quartette™ (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets for the Prevention of Pregnancy
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that
the U.S. Food and Drug Administration (FDA) has approved Quartette
(levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets for the
prevention of pregnancy. Quartette represents the next generation of
extended regimen oral contraceptives to be approved by the FDA, and was
designed to minimize breakthrough bleeding (BTB) between scheduled
periods. The approval of Quartette demonstrates Tevas continued
commitment to the development and production of an innovative range of
pharmaceutical products that support the health of women around the
Breakthrough bleeding can be experienced with any birth control pill,
especially during the first few months, and is one of the reasons a
large number of women discontinue extended regimens, said Dr. James A.
Simon, clinical professor of Obstetrics and Gynecology at the George
Washington University School of Medicine. The estrogen in Quartette
increases at specific points and provides four short light periods a
year. Breakthrough bleeding decreases over time, which might help
encourage patient adherence.
The approval was based on a development program that included results
from Phase I, Phase II and Phase III clinical trials designed to
evaluate the safety and efficacy of Quartette. The Phase III clinical
trial, which involved more than 3,000 women, found that Quartette was
97 percent effective at preventing pregnancy. Data further demonstrated
that the most common adverse reactions (=2%) in the Phase III clinical
trial were headaches, heavy/irregular vaginal bleeding, nausea/vomiting,
acne, dysmenorrhea, weight increased, mood changes, anxiety/panic
attack, breast pain and migraines. The primary clinical trial that
evaluated the efficacy of Quartette also assessed BTB. BTB and
unscheduled spotting decreased over successive 91 day cycles.
Quartette features a unique 91-day oral regimen, whereby the dose of
estrogen increases at three distinct points over the first 84 days and
the amount of progestin remains consistent; this is followed by seven
days of 10 mcg of ethinyl estradiol.
Teva is the leader in the pharmaceutical industry in the marketing and
development of extended regimen oral contraceptives, and Quartette
represents the next generation of these contraceptives. It is a uniquely
differentiated product and is based on Tevas research into when
breakthrough bleeding is most likely to occur with these regimens, said
Jill DeSimone, senior vice president & general manager, Global Teva
Women's Health. Quartette is the newest product in our global womens
health franchise and is an example of our dedication to providing a
variety of contraceptive and family planning options that fit womens
Quartette (levonorgestrel/ethinyl estradiol and ethinyl
estradiol) tablets are indicated for use by women to prevent pregnancy.
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.
here to see the full prescribing information, including Boxed
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic
drugs as well as innovative and specialty pharmaceuticals and active
pharmaceutical ingredients. Headquartered in Israel, Teva is the world's
leading generic drug maker, with a global product portfolio of more than
1,000 molecules and a direct presence in about 60 countries. Teva's
branded businesses focus on CNS, oncology, pain, respiratory and women's
health therapeutic areas as well as biologics. Teva currently employs
approximately 46,000 people around the world and reached $20.3 billion
in net revenues in 2012.
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Source: Teva Pharmaceutical Industries Ltd.