|View printer-friendly version|
|June 27, 2016 8:31 a.m.|
|Teva and Antares Pharma Announce Launch of Generic Imitrex® in the United States|
Approximately 36 million people in the U.S. suffer from migraine and its various characteristics. According to the American Migraine Study II, 85 percent of respondents experience throbbing pain, 80 percent experience sensitivity to light, 76 percent experience sensitivity to sound and 73 percent experience nausea.
"We are pleased to add sumatriptan injection to our growing portfolio
through our successful partnership with Antares,” stated
Teva remains committed to strengthening its presence in the treatment of
migraine and its generic injectable business globally. Teva continues
investment in new, and higher-value generic injectable products. With
approximately 370 generic medicines available, Teva has the largest
“We are delighted to offer this product to patients in
Sumatriptan injection had annual sales of approximately
About Sumatriptan Injection
Sumatriptan injection is indicated in adults for the acute treatment of migraine, with or without aura, and the acute treatment of cluster headache. Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine or cluster headache attack treated with sumatriptan injection, reconsider the diagnosis before sumatriptan injection is administered to treat any subsequent attacks. Sumatriptan injection is not indicated for the prevention of migraine or cluster headache attacks.
Important Safety Information
Sumatriptan injection is contraindicated in patients with: ischemic coronary artery disease or coronary artery vasospasm, including Prinzmetal’s angina; Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders; history of stroke or transient ischemic attack (TIA) or history of hemiplegic or basilar migraine; peripheral vascular disease; ischemic bowel disease; uncontrolled hypertension; recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication, or another 5-HT1 agonist; concurrent administration of a MAO-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor; hypersensitivity to sumatriptan; or severe hepatic impairment.
Serious adverse reactions associated with the use of sumatriptan or 5-HT1 agonists include: myocardial ischemia/infarction, Prinzmetal’s angina; arrhythmias; chest, throat, neck and/or jaw pain/tightness/pressure; cerebral hemorrhage, subarachnoid hemorrhage, and stroke; peripheral vascular ischemia, gastrointestinal vascular ischemia/infarction, splenic infarction, and Raynaud’s syndrome; medication overuse headache; serotonin syndrome; significant elevation in blood pressure; anaphylactic/anaphylactoid reactions; and seizures.
In clinical trials, the most commonly reported adverse reactions (≥5% and > placebo) for sumatriptan injection were injection site reactions, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness.
For more information, please see the accompanying Full Prescribing Information.
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 consummate the acquisition of
ANTARES PHARMASAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains forward-looking statements within the
meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements are subject to
certain risks and uncertainties that can cause actual results to differ
materially from those described. Factors that may cause such differences
include, but are not limited to: market acceptance and the amount of
revenue from VIBEX® Sumatriptan Injection USP in
1 Initrex® is a registered trademark of GSK group of companies.
Teva Pharmaceutical Industries Ltd.