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|September 25, 2017 2:29 p.m.|
|Teva Announces Reintroduction of Generic Depo-Provera® in the United States|
“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
Medroxyprogesterone acetate injectable suspension, USP 150 mg/mL had
annual sales of approximately
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 Information
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.
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:
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
Teva Pharmaceutical Industries Ltd.