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|December 11, 2017 9:15 a.m.|
|Teva Announces Exclusive Launch of a Generic Version Viagra® Tablets in the United States|
Company offers wraparound services to improve patient access to sildenafil tablets
Sildenafil tablets are a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED).
"The launch of Teva's sildenafil tablets brings an affordable generic treatment option to the estimated 18 million men in the U.S. who are diagnosed with erectile dysfunction," said Brendan O'Grady, Executive Vice President, North America Commercial at Teva. "Our team has made it a priority to ensure that patients are able to access this medicine—through both traditional and more innovative channels."
Teva is also offering wraparound services to support patients, such as a sildenafil tablets savings card with which people who meet certain requirements are eligible to participate in the program and may pay as little as $0 out-of-pocket with a maximum benefit of up to
TevaSildenafil.com includes information on how patients may order their medicine online and have it shipped directly to them as well as how to obtain it through traditional retail channels. Additionally, patients can call Teva customer service, 1-888
With nearly 600 generic medicines available, Teva has the largest portfolio of
Viagra® had annual sales of approximately
About Sildenafil Tablets
Sildenafil tablets are indicated for the treatment of erectile dysfunction.
Important Safety Information
Sildenafil tablets were shown to potentiate the hypotensive effects of nitrates, and their administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is contraindicated. Sildenafil tablets are contraindicated in patients with a known hypersensitivity to sildenafil, as contained in sildenafil tablets and REVATIO®2, or any component of the tablet. Do not use sildenafil tablets in patients who are using a GC stimulator, such as riociguat. Sildenafil tablets may potentiate the hypotensive effects of GC stimulators.
Due to the potential for cardiac risk, sildenafil tablets should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. Prolonged erection greater than 4 hours and priapism have been reported infrequently. Sildenafil tablets should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).
Other possible serious adverse reactions include: a sudden loss of vision in one or both eyes which may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition and a cause of decreased vision including permanent loss of vision; and a sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness.
Concomitant use of sildenafil tablets and alpha-blockers or anti-hypertensives may lead to hypotension. The concomitant administration of sildenafil tablets and the protease inhibitor ritonavir substantially increases serum concentrations of sildenafil. There have been postmarketing reports of bleeding events in patients who have taken sildenafil.
The most common adverse reactions reported in clinical trials (≥2%) were headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.
For more information, please see accompanying Full Prescribing 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 Viagra®, 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 Viagra® is a registered trademark of
Teva Pharmaceutical Industries Ltd.