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|October 12, 2016 10:00 a.m.|
|Teva Announces Launch of Generic Beyaz® in the United States|
Teva is committed to strengthening its generics business through
continued investment in complex, high-quality products. With nearly 600
generic medicines available, Teva has the largest portfolio of
Teva has over 300 product registrations pending
Beyaz® had annual sales of approximately
RAJANITM is indicated for use by women to prevent pregnancy. RAJANITM does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
RAJANITM is indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of RAJANITM for PMDD when used for more than three menstrual cycles has not been evaluated. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders. RAJANITM has not been evaluated for the treatment of premenstrual syndrome (PMS).
RAJANITM is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. RAJANITM should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
RAJANITM is indicated in women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.
Important Safety Information
WARNING: Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (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 should not be used by women who are over 35 years of age and smoke.
RAJANITM is contraindicated in women who are known to have the following: renal impairment; adrenal insufficiency; a high risk of arterial or venous thrombotic diseases; undiagnosed abnormal uterine bleeding; breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past; liver tumors, benign or malignant, or liver disease; or pregnancy.
COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. RAJANITM contains 3 mg of the progestin DRSP, which has antimineralocorticoid activity, including the potential for hyperkalemia in high-risk patients. Other serious adverse reactions associated with the use of COCs include: carcinoma of breast or cervix; impaired liver function or liver tumors; hypertension; gallbladder disease; carbohydrate and lipid metabolic effects; new or worsening headaches, including migraines; bleeding irregularities; depression; elevations of binding globulins; angioedema; and chloasma.
The most frequent adverse reactions (greater than or equal to 2%) in contraception, acne and folate clinical trials are headache/migraine (5.9%), menstrual irregularities (4.1%), nausea/vomiting (3.5%) and breast pain/tenderness (3.2%).
The most frequent adverse reactions (greater than or equal to 2%) in PMDD clinical trials are menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%).
For more information, please see accompanying full Prescribing Information, including the boxed warnings.
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 specialty products, especially Copaxone® (which
faces competition from orally-administered alternatives and a generic
version); our ability to integrate
1 Beyaz® is a registered trademark of
Teva Pharmaceutical Industries Ltd.