Teva Announces Reintroduction of Generic Depo-Provera® in the United States
September 25 2017 - 2:29PM
Business Wire
Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) today
announced the reintroduction of the generic equivalent to
Depo-Provera®1 Contraceptive Injection (medroxyprogesterone acetate
injectable suspension, USP) 150 mg/mL, in the United States.
Medroxyprogesterone acetate injectable suspension is a progestin
indicated only for the prevention of pregnancy.
“This reintroduction brings an additional product to a market
that was previously lacking in options,” said Dr. Hafrun
Fridriksdottir, Executive Vice President, President of Global
Generics R&D. “In addition to its importance to patients who
will benefit from access to this medicine, this reintroduction
holds significant importance to Teva and our generics R&D
priorities.”
Teva has been committed to strengthening its generic injectable
business globally, by making continued investment in newer,
higher-value generic injectable products. 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 generic product.
Medroxyprogesterone acetate injectable suspension, USP 150 mg/mL
had annual sales of approximately $211 million in the United
States, according to IMS data as of July 2017.
About Medroxyprogesterone Acetate Injectable Suspension,
USP
Medroxyprogesterone acetate injectable suspension is indicated
only for the prevention of pregnancy. The loss of bone mineral
density (BMD) in women of all ages and the impact on peak bone mass
in adolescents should be considered, along with the decrease in BMD
that occurs during pregnancy and/or lactation, in the risk/benefit
assessment for women who use medroxyprogesterone acetate injectable
suspension long-term.
Important Safety
InformationWomen who use medroxyprogesterone acetate
injectable suspension may lose significant bone mineral density.
Bone loss is greater with increasing duration of use and may not be
completely reversible. Medroxyprogesterone acetate injectable
suspension should not be used as a long-term birth control method
(i.e., longer than 2 years) unless other birth control methods are
considered inadequate.
The use of medroxyprogesterone acetate injectable suspension is
contraindicated in the following conditions: known or suspected
pregnancy or as a diagnostic test for pregnancy; active
thrombophlebitis, or current or past history of thromboembolic
disorders, or cerebral vascular disease; known or suspected
malignancy of breast; known hypersensitivity to medroxyprogesterone
acetate injectable suspension or any of its other ingredients;
significant liver disease; or undiagnosed vaginal bleeding.
Studies have shown an increased risk of breast cancer in women
using medroxyprogesterone acetate injectable suspension. Serious
thrombotic events; anaphylaxis and anaphylactoid reaction;
injection site reactions; convulsions; weight gain; and decreased
glucose tolerance have been reported with the use of
medroxyprogesterone acetate injectable suspension.
In clinical trials the most common adverse reactions (incidence
> 5%) were: menstrual irregularities (bleeding or spotting),
abdominal pain/discomfort, dizziness, headache, nervousness, and
decreased libido. Medroxyprogesterone acetate injectable suspension
does not protect against HIV infection (AIDS) and other sexually
transmitted diseases.
For more information, 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 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 Depo-Provera®, 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 generic
version of medroxyprogesterone acetate injectable;
- 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 Depo-Provera® is a registered trademark of Pfizer,
Inc.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170925006258/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:Kevin C.
Mannix, United States, 215-591-8912Ran Meir, United
States, 215-591-3033Tomer Amitai, Israel, 972 (3)
926-7656orPR Contacts:Iris Beck Codner, Israel, 972 (3)
926-7208Denise Bradley, United States, 215-591-8974
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Apr 2023 to Apr 2024