Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of an authorized generic of Estrace®1 Cream
(estradiol vaginal cream, USP, 0.01%), in the U.S.
Estradiol vaginal cream, USP, 0.01%, is indicated in the
treatment of moderate to severe symptoms of vulvar and vaginal
atrophy due to menopause. This launch is an important addition to
Teva’s generic women’s health portfolio and our growing line of
menopause treatments.
With nearly 600 generic medicines available, Teva has the
largest portfolio of FDA-approved generic products on the market
and holds the leading position in first-to-file opportunities, with
over 100 pending first-to-files in the U.S. Currently, one in seven
generic prescriptions dispensed in the U.S. is filled with a Teva
product.
Estradiol Vaginal Cream 0.01% had annual sales of approximately
$426 million in the U.S., according to IMS data as of August
2017.
About Estradiol Vaginal Cream, USP, 0.01%
INDICATIONS AND USAGE
Estradiol Vaginal Cream, USP is indicated in the treatment of
moderate to severe symptoms of vulvar and vaginal atrophy due to
menopause.
IMPORTANT SAFETY INFORMATION
WARNINGS: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS,
BREAST CANCER AND PROBABLE DEMENTIA
There is an increased risk of endometrial cancer in a woman with
a uterus who uses unopposed estrogens. Adding a progestin to
estrogen therapy has been shown to reduce the risk of endometrial
hyperplasia, which may be a precursor to endometrial cancer.
Adequate diagnostic measures, including directed or random
endometrial sampling when indicated, should be undertaken to rule
out malignancy in postmenopausal women with undiagnosed persistent
or recurring abnormal genital bleeding.
Estrogens with or without progestins should not be used for the
prevention of cardiovascular disease or dementia.
The Women's Health Initiative (WHI) estrogen-alone substudy
reported increased risks of stroke and deep vein thrombosis (DVT)
in postmenopausal women with daily oral conjugated estrogens (CE)
alone. The WHI estrogen-plus-progestin substudy reported increased
risks of DVT, pulmonary embolism, stroke, and myocardial infarction
in postmenopausal women with daily oral CE combined with
medroxyprogesterone acetate (MPA). In the absence of comparable
data, these risks should be assumed to be similar for other dosage
forms of estrogens.
The Women’s Health Initiative Memory Study (WHIMS), a substudy
of WHI, reported increased risk of developing probable dementia in
postmenopausal women 65 years of age or older during 4 years of
treatment with oral conjugated estrogens-plus-medroxyprogesterone
acetate relative to placebo. It is unknown whether this finding
applies to younger postmenopausal women or to women taking
estrogen-alone therapy.
The WHI estrogen-plus-progestin substudy demonstrated an
increased risk of invasive breast cancer.
Estrogens with or without progestins should be prescribed at the
lowest effective doses and for the shortest duration consistent
with treatment goals and risks for the individual woman.
Estradiol Vaginal Cream, USP should not be used in: women
with undiagnosed abnormal genital bleeding; known, suspected or
history of breast cancer; known or suspected estrogen-dependent
neoplasia; active deep vein thrombosis, pulmonary embolism or a
history of these conditions; active arterial thromboembolic disease
(for example, stroke, myocardial infarction) or a history of these
conditions; known anaphylactic reaction or angioedema to Estradiol
Vaginal Cream, USP; liver dysfunction or disease; thrombophilic
disorders; known or suspected pregnancy.
Estrogens increase the risk of gallbladder disease. Discontinue
estrogen if hypercalcemia, sudden partial or complete loss of
vision, hypertriglyceridemia, or cholestatic jaundice occurs.
Patients dependent on thyroid hormone replacement therapy should
have their thyroid function monitored in order to maintain their
free thyroid hormone levels in an acceptable range. Endometriosis
may be exacerbated in women treated post-hysterectomy with
estrogen-alone therapy. The addition of progestins should be
considered in these patients.
The most common side effects include: headache, breast
tenderness, irregular vaginal bleeding or spotting,
stomach/abdominal cramps, bloating, nausea and vomiting, hair loss,
and vaginal burning, irritation, and itching.
Systemic absorption may occur with the use of Estradiol Vaginal
Cream, USP. The warnings, precautions, and adverse reactions
associated with oral estrogen treatment should be taken into
account.
For more information, please follow the link to see 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 used by approximately 200
million patients in over 60 markets 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 the world-leading innovative
treatment for multiple sclerosis as well as late-stage development
programs for other disorders of the central nervous system,
including movement disorders, migraine, pain and neurodegenerative
conditions, as well as a broad portfolio of respiratory products.
Teva is leveraging its generics and specialty capabilities in order
to seek new ways of addressing unmet patient needs by combining
drug development with devices, services and technologies. Teva's
net revenues in 2016 were $21.9 billion. For more information,
visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding the launch and potential benefits of Teva's generic
version of Estrace®, which are based on management’s current
beliefs and expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements.
Important factors that could cause or contribute to such
differences include risks relating to:
- commercial success of Teva's estradiol
vaginal cream;
- our generics medicines business,
including: that we are substantially more dependent on this
business, with its significant attendant risks, following our
acquisition of Allergan plc’s worldwide generic pharmaceuticals
business (“Actavis Generics”); our ability to realize the
anticipated benefits of the acquisition (and any delay in realizing
those benefits) or difficulties in integrating Actavis Generics;
the increase in the number of competitors targeting generic
opportunities and seeking U.S. market exclusivity for generic
versions of significant products; price erosion relating to our
generic products, both from competing products and as a result of
increased governmental pricing pressures; and our ability to take
advantage of high-value biosimilar opportunities;
- our business and operations in general,
including: uncertainties relating to our recent senior management
changes; our ability to develop and commercialize additional
pharmaceutical products; manufacturing or quality control problems,
which may damage our reputation for quality production and require
costly remediation; interruptions in our supply chain; disruptions
of our or third party information technology systems or breaches of
our data security; the failure to recruit or retain key personnel,
including those who joined us as part of the Actavis Generics
acquisition; the restructuring of our manufacturing network,
including potential related labor unrest; the impact of continuing
consolidation of our distributors and customers; variations in
patent laws that may adversely affect our ability to manufacture
our products; adverse effects of political or economic instability,
major hostilities or terrorism on our significant worldwide
operations; and our ability to successfully bid for suitable
acquisition targets or licensing opportunities, or to consummate
and integrate acquisitions; and
- compliance, regulatory and litigation
matters, including: costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; potential additional adverse
consequences following our resolution with the U.S. government of
our FCPA investigation; governmental investigations into sales and
marketing practices; potential liability for sales of generic
products prior to a final resolution of outstanding patent
litigation; product liability claims; increased government scrutiny
of our patent settlement agreements; failure to comply with
complex Medicare and Medicaid reporting and payment
obligations; and environmental risks.
and other factors discussed in our Annual Report on Form 20-F
for the year ended December 31, 2016 (“Annual Report”)
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 contained herein, whether as a result of new
information, future events or otherwise. You are cautioned not to
rely on these forward-looking statements. You are advised to
consult any additional disclosures we make in our reports to
the SEC on Form 6-K, as well as the cautionary discussion of
risks and uncertainties under “Risk Factors” in our Annual Report.
These are factors that we believe could cause our actual results to
differ materially from expected results. Other factors besides
those listed could also materially and adversely affect us. This
discussion is provided as permitted by the Private Securities
Litigation Reform Act of 1995.
###
1 Estrace is a registered trademark of Allergan Pharmaceuticals
International Limited
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version on businesswire.com: http://www.businesswire.com/news/home/20180102005702/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United StatesKevin C. Mannix,
215-591-8912Ran Meir, 215-591-3033orIsraelTomer
Amitai, 972 (3) 926-7656orPR
Contacts:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesElizabeth DeLuca, 484-612-5407
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