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|March 01, 2017 10:56 a.m.|
|Teva Announces Launch of Generic Pristiq® in the United States|
Desvenlafaxine extended-release tablets are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder.
Desvenlafaxine extended-release tablets further enhance Teva’s portfolio
of antidepressant products. With nearly 600 generic medicines available,
Teva has the largest portfolio of
Pristiq® had annual sales of approximately
About Desvenlafaxine Extended-Release Tablets
Desvenlafaxine extended-release tablets, a SNRI, are indicated for the treatment of major depressive disorder (MDD). The efficacy of desvenlafaxine extended-release tablets has been established in four short-term (8-week, placebo-controlled studies) and two maintenance studies in adult outpatients who met DSM-IV criteria for MDD.
Important Safety Information
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS: Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. Desvenlafaxine extended-release tablets are not approved for use in pediatric patients.
Desvenlafaxine extended-release tablets are contraindicated in patients with hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the desvenlafaxine extended-release tablets formulation. Angioedema has been reported in patients treated with desvenlafaxine extended-release tablets. The use of MAOIs intended to treat psychiatric disorders with desvenlafaxine extended-release tablets or within 7 days of stopping treatment with desvenlafaxine extended-release tablets is contraindicated because of an increased risk of serotonin syndrome. The use of desvenlafaxine extended-release tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated. Starting desvenlafaxine extended-release tablets in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.
The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including desvenlafaxine extended-release tablets, alone but particularly with concomitant use of other serotonergic drugs, and with drugs that impair metabolism of serotonin, in particular MAOIs (see contraindications above). Other serious adverse reactions reported with use of desvenlafaxine extended-release tablets or the parent drug, venlafaxine include elevated blood pressure, abnormal bleeding, angle closure glaucoma, activation of mania/hypomania, discontinuation syndrome, seizure, hyponatremia, and interstitial lung disease and eosinophilic pneumonia.
The most commonly observed adverse reactions in desvenlafaxine extended-release tablets treated MDD patients in clinical studies (incidence greater than or equal to 5% and at least twice the rate of placebo in the 50 or 100 mg dose groups) were nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders.
For more information, please see accompanying Full Prescribing Information, including Boxed Warning.
Teva's Safe Harbor Statement under the
This press release contains forward-looking statements, 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
1 Pristiq® is a registered trademark of
Teva Pharmaceutical Industries Ltd.