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JERUSALEM--(BUSINESS WIRE)--Jan. 2, 2018--
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
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
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
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.
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,
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
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
1 Estrace is a registered trademark of Allergan
Pharmaceuticals International Limited
View source version on businesswire.com: http://www.businesswire.com/news/home/20180102005702/en/
Source: Teva Pharmaceutical Industries Ltd.
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