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|January 05, 2016 8:00 a.m.|
|Teva Announces Launch of Generic Ortho Tri-Cyclen® Lo in the United States|
As a leading global pharmaceutical company, Teva is committed to care in women’s health with a portfolio including contraceptive products and other therapies.
Ortho Tri-Cyclen® Lo (norgestimate/ethinyl estradiol)
tablets, marketed by
Tri-Lo-Sprintec is indicated for use by females of reproductive potential to prevent pregnancy. Tri-Lo-Sprintec does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Important Safety Information
Cigarette smoking increases the risk of serious cardiovascular side effects from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke.
Tri-Lo-Sprintec is contraindicated in women who are known to have the following conditions: a high risk of arterial or venous thrombotic diseases; liver tumors, benign or malignant, or liver disease; undiagnosed abnormal uterine bleeding; pregnancy; or breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past.
Serious adverse reactions associated with the use of COCs include: thromboembolic disorders and other vascular problems; impaired liver function or liver tumors; hypertension, gallbladder disease; carbohydrate and lipid metabolic effects; new or worsening of headaches, including migraines; bleeding irregularities and amenorrhea, depression; carcinoma of breast and cervix; elevations of binding globulins, angioedema, and chloasma.
The most common adverse events reported during clinical trials (≥2%) were: headache/migraine, nausea/vomiting, breast issues, abdominal pain, menstrual disorders, mood disorders, acne, vulvovaginal infection, abdominal distension, weight increased, and fatigue.
For more information, please see accompanying full Prescribing Information, including Boxed Warning.
Teva's Safe Harbor Statement under the
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our innovative products, especially Copaxone®
(including competition from orally-administered alternatives, as well as
from potential purported generic equivalents) and our ability to
migrate users to our 40 mg/mL version; the possibility of material
fines, penalties and other sanctions and other adverse consequences
arising out of our ongoing FCPA investigations and related matters; our
ability to achieve expected results from the research and development
efforts invested in our pipeline of specialty and other products; our
ability to reduce operating expenses to the extent and during the
timeframe intended by our cost reduction program; our ability to
identify and successfully bid for suitable acquisition targets or
licensing opportunities, or to consummate and integrate acquisitions;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
increased government scrutiny in both the U.S. and
Teva Pharmaceutical Industries Ltd.