Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of RAJANITM (drospirenone, ethinyl estradiol
and levomefolate calcium tablets, 3 mg/0.02 mg/0.451 mg and
levomefolate calcium tablets, 0.451 mg) in the United States.
RAJANITM, the generic equivalent of Beyaz®1, is an oral
contraceptive, available in a 28-day blister pack dispenser, for
use by women to:
- prevent pregnancy;
- treat symptoms of premenstrual
dysphoric disorder (PMDD) in women choosing to use an oral
contraceptive for contraception;
- treat moderate acne for women at least
14 years old if the patient desires an oral contraceptive for birth
control; and
- raise folate levels in women who choose
to use an oral contraceptive for contraception.
Teva is committed to strengthening its generics business through
continued investment in complex, high-quality products. With nearly
600 generic medicines available, Teva has the largest portfolio of
FDA-approved generic products on the market. This product
enhances Teva’s already comprehensive oral contraceptive
portfolio.
Teva has over 300 product registrations pending FDA approval and
holds the leading position in first-to-file opportunities, with
over 100 pending first-to-files in the U.S. Currently, one in six
generic prescriptions dispensed in the U.S. is filled with a Teva
generic product.
Beyaz® had annual sales of approximately $133 million in the
U.S., according to IMS data as of July 2016.
About RAJANITM
RAJANITM is indicated for
use by women to prevent pregnancy. RAJANITM does not protect against HIV infection
(AIDS) and other sexually transmitted diseases.
RAJANITM is indicated for
the treatment of symptoms of premenstrual dysphoric disorder (PMDD)
in women who choose to use an oral contraceptive as their method of
contraception. The effectiveness of RAJANITM for PMDD when used for more than three
menstrual cycles has not been evaluated. Diagnosis is made by
healthcare providers according to DSM-IV criteria, with
symptomatology assessed prospectively over at least two menstrual
cycles. In making the diagnosis, care should be taken to rule out
other cyclical mood disorders. RAJANITM has not been evaluated for the treatment
of premenstrual syndrome (PMS).
RAJANITM is indicated for
the treatment of moderate acne vulgaris in women at least 14 years
of age, who have no known contraindications to oral contraceptive
therapy and have achieved menarche. RAJANITM should be used for the treatment of acne
only if the patient desires an oral contraceptive for birth
control.
RAJANITM is indicated in
women who choose to use an oral contraceptive as their method of
contraception, to raise folate levels for the purpose of reducing
the risk of a neural tube defect in a pregnancy conceived while
taking the product or shortly after discontinuing the product.
Important Safety Information
WARNING: Cigarette smoking increases the risk of serious
cardiovascular events from combination oral contraceptives (COC)
use. This risk increases with age, particularly in women over 35
years of age, and with the number of cigarettes smoked. For this
reason, COCs should not be used by women who are over 35 years of
age and smoke.
RAJANITM is contraindicated
in women who are known to have the following: renal impairment;
adrenal insufficiency; a high risk of arterial or venous thrombotic
diseases; undiagnosed abnormal uterine bleeding; breast cancer or
other estrogen- or progestin-sensitive cancer, now or in the past;
liver tumors, benign or malignant, or liver disease; or
pregnancy.
COCs may be associated with a higher risk of venous
thromboembolism (VTE) than COCs containing the progestin
levonorgestrel or some other progestins. Use of COCs also increases
the risk of arterial thromboses such as strokes and myocardial
infarctions, especially in women with other risk factors for these
events. RAJANITM contains 3 mg
of the progestin DRSP, which has antimineralocorticoid activity,
including the potential for hyperkalemia in high-risk patients.
Other serious adverse reactions associated with the use of COCs
include: carcinoma of breast or cervix; impaired liver function or
liver tumors; hypertension; gallbladder disease; carbohydrate and
lipid metabolic effects; new or worsening headaches, including
migraines; bleeding irregularities; depression; elevations of
binding globulins; angioedema; and chloasma.
The most frequent adverse reactions (greater than or equal to
2%) in contraception, acne and folate clinical trials are
headache/migraine (5.9%), menstrual irregularities (4.1%),
nausea/vomiting (3.5%) and breast pain/tenderness (3.2%).
The most frequent adverse reactions (greater than or equal to
2%) in PMDD clinical trials are menstrual irregularities (24.9%),
nausea (15.8%), headache (13.0%), breast tenderness (10.5%),
fatigue (4.2%), irritability (2.8%), decreased libido (2.8%),
increased weight (2.5%), and affect lability (2.1%).
For more information, please see accompanying full Prescribing
Information, including the boxed warnings.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by millions of patients
every day. Headquartered in Israel, Teva is the world’s largest
generic medicines producer, leveraging its portfolio of more than
1,800 molecules to produce a wide range of generic products in
nearly every therapeutic area. In specialty medicines, Teva has a
world-leading position in innovative treatments for disorders of
the central nervous system, including pain, as well as a strong
portfolio of respiratory products. Teva integrates its generics and
specialty capabilities in its global research and development
division to create new ways of addressing unmet patient needs by
combining drug development capabilities with devices, services and
technologies. Teva's net revenues in 2015 amounted to $19.7
billion. For more information, visit www.tevapharm.com.
Teva's Safe Harbor Statement under the U. S. Private
Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which 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 specialty
products, especially Copaxone® (which faces competition from
orally-administered alternatives and a generic version); our
ability to integrate Allergan plc’s worldwide generic
pharmaceuticals business (“Actavis Generics”) and to realize the
anticipated benefits of the acquisition (and the timing of
realizing such benefits); the fact that following the consummation
of the Actavis Generics acquisition, we are dependent to a much
larger extent than previously on our generic pharmaceutical
business; potential restrictions on our ability to engage in
additional transactions or incur additional indebtedness as a
result of the substantial amount of debt incurred to finance the
Actavis Generics acquisition; the fact that for a period of time
following the Actavis Generics acquisition, we will have
significantly less cash on hand than previously, which could
adversely affect our ability to grow; the possibility of material
fines, penalties and other sanctions and other adverse consequences
arising out of our ongoing FCPA investigations and related matters;
our ability to achieve expected results from investments in our
pipeline of specialty and other products; our ability to identify
and successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions; the
extent to which any manufacturing or quality control problems
damage our reputation for quality production and require costly
remediation; increased government scrutiny in both the U.S. and
Europe of our patent settlement agreements; our exposure to
currency fluctuations and restrictions as well as credit risks; the
effectiveness of our patents, confidentiality agreements and other
measures to protect the intellectual property rights of our
specialty medicines; the effects of reforms in healthcare
regulation and pharmaceutical pricing, reimbursement and coverage;
competition for our generic products, both from other
pharmaceutical companies and as a result of increased governmental
pricing pressures; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical
products; adverse effects of political or economic instability,
major hostilities or acts of terrorism on our significant worldwide
operations; interruptions in our supply chain or problems with
internal or third-party information technology systems that
adversely affect our complex manufacturing processes; significant
disruptions of our information technology systems or breaches of
our data security; competition for our specialty pharmaceutical
businesses from companies with greater resources and capabilities;
the impact of continuing consolidation of our distributors and
customers; decreased opportunities to obtain U.S. market
exclusivity for significant new generic products; potential
liability in the U.S., Europe and other markets for sales of
generic products prior to a final resolution of outstanding patent
litigation; our potential exposure to product liability claims that
are not covered by insurance; any failure to recruit or retain key
personnel, or to attract additional executive and managerial
talent; any failures to comply with complex Medicare and Medicaid
reporting and payment obligations; significant impairment charges
relating to intangible assets, goodwill and property, plant and
equipment; the effects of increased leverage and our resulting
reliance on access to the capital markets; potentially significant
increases in tax liabilities; the effect on our overall effective
tax rate of the termination or expiration of governmental programs
or tax benefits, or of a change in our business; variations in
patent laws that may adversely affect our ability to manufacture
our products in the most efficient manner; environmental risks; and
other factors that are discussed in our Annual Report on Form 20-F
for the year ended December 31, 2015 and in our other filings with
the U.S. Securities and Exchange Commission (the "SEC").
Forward-looking statements speak only as of the date on which they
are made and we assume no obligation to update or revise any
forward-looking statements or other information, whether as a
result of new information, future events or otherwise.
1 Beyaz® is a registered trademark of Bayer Healthcare.
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version on businesswire.com: http://www.businesswire.com/news/home/20161012005897/en/
Teva Pharmaceutical Industries Ltd.IR:United StatesKevin C.
Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley,
215-591-8974orNancy Leone, 215-284-0213
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