Teva Enhances Extensive Women’s Health Portfolio with Launch of Generic Lomedia® 24 Fe Tablets
29 Mai 2015 - 2:30PM
Business Wire
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announces the
launch of the generic equivalent of Lomedia® 24 Fe
(norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/20
mcg and ferrous fumarate tablets, 75 mg) as part of the extensive
line of Women’s Health products. The product will be launched under
the name Junel® Fe 24 (norethindrone acetate and ethinyl estradiol
tablets USP and ferrous fumarate tablets) and is now available in
the United States.
Teva recognizes that women’s needs change over time and the
portfolio of Women’s Health products is positioned to support women
through many stages of life. With the addition of Junel® Fe 24,
Teva can offer women a comprehensive line of nearly 30 generic
contraceptive products.
Lomedia® 24 Fe marketed by Amneal had annual sales of
approximately $32 million in the United States, according to IMS
data as of December 2014.
About Junel® Fe 24 Tablets
Junel® Fe 24 is indicated for the prevention of pregnancy in
women who elect to use oral contraceptives as a method of
contraception. Patients should be counseled that this product does
not protect against HIV infection (AIDS) and other sexually
transmitted diseases.
Important Safety Information
Cigarette smoking increases the risk of serious cardiovascular
side effects from oral contraceptive use. This risk increases with
age and with the extent of smoking (in epidemiologic studies, 15 or
more cigarettes per day was associated with a significantly
increased risk) and is quite marked in women over 35 years of age.
Women who use oral contraceptives should be strongly advised not to
smoke.
Oral contraceptives should not be used in women who currently
have the following conditions: thrombophlebitis or thromboembolic
disorders; a past history of deep vein thrombophlebitis or
thromboembolic disorders; cerebrovascular or coronary artery
disease (current or history); valvular heart disease with
thrombogenic complications; severe hypertension; diabetes with
vascular involvement; headaches with focal neurological symptoms;
major surgery with prolonged immobilization; known or suspected
carcinoma of the breast or personal history of breast cancer;
carcinoma of the endometrium or other known or suspected
estrogen-dependent neoplasia; undiagnosed abnormal genital
bleeding; cholestatic jaundice of pregnancy or jaundice with prior
pill use; hepatic adenomas or carcinomas, or active liver disease;
known or suspected pregnancy; hypersensitivity to any component of
this product.
An increased risk of the following serious adverse reactions has
been associated with the use of oral contraceptives:
thrombophlebitis; arterial thromboembolism; pulmonary embolism;
myocardial infarction; cerebral hemorrhage; cerebral thrombosis;
hypertension; gallbladder disease; and hepatic adenomas or benign
liver tumors.
The most common adverse events reported by 2 to 6% of the 743
women using Junel Fe 24 were the following, in order of decreasing
incidence: headache, vaginal candidiasis, upper respiratory
infection, nausea, menstrual cramps, breast tenderness, sinusitis,
vaginitis (bacterial), abnormal cervical smear, acne, urinary tract
infection, mood swings, weight gain, vomiting, and
metrorrhagia.
Please see accompanying Full Prescribing Information, including Boxed Warning.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) is
a leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to millions of patients every
day. Headquartered in Israel, Teva is the world’s largest
generic medicines producer, leveraging its portfolio of more than
1,000 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 2014 amounted to $20.3
billion. For more information, visit www.tevapharm.com.
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 innovative
products, especially Copaxone® (including competition from
orally-administered alternatives, as well as from potential
purported generic equivalents) and our ability to migrate users to
our 40 mg/mL version; 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 the research and development efforts
invested in our pipeline of specialty and other products; our
ability to reduce operating expenses to the extent and during the
timeframe intended by our cost reduction program; 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; 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 generic products, both from
other pharmaceutical companies and as a result of increased
governmental pricing pressures; 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, 2014 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 we
assume no obligation to update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
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version on businesswire.com: http://www.businesswire.com/news/home/20150529005174/en/
IR:Kevin C. Mannix, 215-591-8912United StatesorRan
Meir, 215-591-3033United StatesorTomer Amitai, 972 (3)
926-7656IsraelorPR:Denise Bradley, 215-591-8974United
StatesorIris Beck Codner, 972 (3) 926-7687Israel
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