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|August 18, 2017 1:37 p.m.|
|Teva Announces Exclusive Launch of Generic Axiron® in the United States|
Testosterone topical solution CIII is a prescription medicine used to treat adult males who have low or no testosterone due to certain medical conditions. It is supplied in a metered dose pump with an underarm applicator.
“We are pleased with the result in the district court, which has helped
Teva add yet another product to our industry-leading generic portfolio,
providing savings to our customers and to patients,” said
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
Axiron® had annual sales of approximately
About Testosterone Topical Solution CIII
Testosterone topical solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (FSH, LH) above the normal range.
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range.
Limitations of use: Safety and efficacy of testosterone topical solution in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. Safety and efficacy of testosterone topical solution in males less than 18 years old have not been established.
Due to lack of controlled studies in women and potential virilizing effects, testosterone topical solution is not indicated for use in women.
Important Safety Information
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE. Virilization has been reported in children who were secondarily exposed to topical testosterone products. Children should avoid contact with unwashed or unclothed application sites in men using testosterone topical solution. Healthcare providers should advise patients to strictly adhere to recommended instructions for use.
Testosterone topical solution is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. Testosterone topical solution is contraindicated in women who are, or who may become pregnant, or who are breastfeeding. Testosterone topical solution may cause fetal harm when administered to a pregnant woman. Testosterone topical solution may cause serious adverse reactions in nursing infants. If a pregnant woman is exposed to testosterone topical solution, she should be apprised of the potential hazard to the fetus.
Other serious risks include: worsening of benign prostatic hyperplasia, potential risk of prostate cancer, polycythemia, venous thromboembolism, cardiovascular risk, potential for adverse effects on spermatogenesis, hepatic adverse effects, edema, gynecomastia, sleep apnea, changes in serum lipid profile, hypercalcemia, and decreased thyroxine-binding globulin.
Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions.
In clinical trials, the most common adverse reactions (incidence greater
than 4%) were skin application site reactions, increased hematocrit,
headache, diarrhea, vomiting, and increased serum prostate specific
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 Axiron®, 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 AXIRON is a registered trademark of
Teva Pharmaceutical Industries Ltd.