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|May 29, 2015 8:31 a.m.|
|Teva Enhances Extensive Women’s Health Portfolio with Launch of Generic Lomedia® 24 Fe Tablets|
Teva recognizes that women’s needs change over time and the portfolio of Women’s Health products is positioned to support women through many stages of life. With the addition of Junel® Fe 24, Teva can offer women a comprehensive line of nearly 30 generic contraceptive products.
Lomedia® 24 Fe marketed by Amneal had annual sales of
About Junel® Fe 24 Tablets
Junel® Fe 24 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Patients should be counseled that this product 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 oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
Oral contraceptives should not be used in women who currently have the following conditions: thrombophlebitis or thromboembolic disorders; a past history of deep vein thrombophlebitis or thromboembolic disorders; cerebrovascular or coronary artery disease (current or history); valvular heart disease with thrombogenic complications; severe hypertension; diabetes with vascular involvement; headaches with focal neurological symptoms; major surgery with prolonged immobilization; known or suspected carcinoma of the breast or personal history of breast cancer; carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia; undiagnosed abnormal genital bleeding; cholestatic jaundice of pregnancy or jaundice with prior pill use; hepatic adenomas or carcinomas, or active liver disease; known or suspected pregnancy; hypersensitivity to any component of this product.
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives: thrombophlebitis; arterial thromboembolism; pulmonary embolism; myocardial infarction; cerebral hemorrhage; cerebral thrombosis; hypertension; gallbladder disease; and hepatic adenomas or benign liver tumors.
The most common adverse events reported by 2 to 6% of the 743 women using Junel Fe 24 were the following, in order of decreasing incidence: headache, vaginal candidiasis, upper respiratory infection, nausea, menstrual cramps, breast tenderness, sinusitis, vaginitis (bacterial), abnormal cervical smear, acne, urinary tract infection, mood swings, weight gain, vomiting, and metrorrhagia.
Please see accompanying Full Prescribing Information, including Boxed Warning.
Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:
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