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|March 29, 2013 8:00 a.m.|
|FDA Approves New Drug Application (NDA) for Teva’s Quartette™ (levonorgestrel/ethinyl estradiol and ethinyl estradiol) Tablets for the Prevention of Pregnancy|
-- Quartette™ Represents the Next Generation of Extended Regimen Oral Contraceptives --
“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.
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.1
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 Teva’s research into when
breakthrough bleeding is most likely to occur with these regimens,” said
Important Safety Information for QuartetteTM
Quartette™ (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets are indicated for use by women to prevent pregnancy.
IMPORTANT SAFETY INFORMATION
WARNING TO WOMEN WHO SMOKE
Do not use Quartette™ if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from birth control pills, including death from heart attack, blood clots, or stroke. The risk increases with age and the number of cigarettes you smoke.
You are encouraged to report negative side effects of prescription drugs
Please click here to see the full prescribing information, including Boxed Warning.
Teva's Safe Harbor Statement under the
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
1 Quartette PI
Teva Pharmaceutical Industries Ltd.