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Pernix Therapeutics Announces Launch of Authorized Generic Version of Treximet® by Company’s Subsidiary, Macoven Pharmaceuticals | ||
By: Nasdaq / GlobeNewswire - 16 Feb 2018 | Back to overview list |
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MORRISTOWN, N.J., Feb. 16, 2018 (GLOBE NEWSWIRE) -- Pernix Therapeutics Holdings, Inc. (NASDAQ:PTX), a specialty pharmaceutical company, today announced the launch of an authorized generic version of Treximet® (sumatriptan/naproxen sodium) in the U.S. by the Company’s subsidiary, Macoven Pharmaceuticals, LLC. Treximet is a prescription medicine that contains sumatriptan and naproxen sodium (a NSAID) and is indicated for the treatment of acute migraine headaches with or without aura in patients 12 years of age and older. “The availability of both a branded and authorized generic version of Treximet demonstrates that Pernix continues to view Treximet as an important part of its business,” said John Sedor, Pernix’s Chairman and Chief Executive Officer. "Through our launch of an authorized generic version of Treximet, Pernix is providing patients and providers with access to a lower-cost treatment for acute migraine headaches.” Despite the launch of an authorized generic, Pernix expects a significant decrease in the sales of Treximet in 2018. Important Safety Information TREXIMET® may increase your chance of a heart attack or stroke that can lead to death. Your chance of a heart attack or stroke increases with longer use of non-steroidal anti-inflammatory drugs (NSAIDs) or if you have heart disease or risk factors for heart disease. Serious allergic or skin reactions, or stomach and intestine problems such as bleeding and ulcers, can occur without warning and may cause death. Risk of stomach and intestinal problems increases in the elderly. Do not take TREXIMET® if you have heart problems, history of heart problems, or right before or after heart bypass surgery; had a stroke, TIAs, or problems with your blood circulation; hemiplegic migraines or basilar migraines; narrowing of blood vessels to your legs and arms, stomach, or kidneys; uncontrolled high blood pressure; an allergy to aspirin, NSAIDs, sumatriptan or any of the ingredients in TREXIMET®; taken any medicines in the last 24 hours that are triptans or contain ergotamine; taken an MAOI antidepressant within the last 2 weeks; during third trimester of pregnancy; or liver problems. TREXIMET® should never be used if you have ever had a heart surgery called a coronary artery bypass graft (CABG). Before you take TREXIMET®, tell your healthcare provider about all of your medical conditions including if you have risk factors for heart disease like high blood pressure, high cholesterol, diabetes, smoking, obesity, and heart problems or a family history of heart problems or stroke; kidney problems; liver problems; history of epilepsy or seizures; are pregnant, think you might be pregnant, or are trying to become pregnant; are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Serotonin syndrome is a rare but serious problem that can happen in people using TREXIMET®, especially if used with antidepressants called SSRIs or SNRIs. The most common side effects of TREXIMET® include: dizziness; feeling weak, drowsy, or tired; pain, discomfort, or stiffness in your neck, throat, jaw, or chest; nausea; tingling or numbness in your fingers or toes; heartburn; dry mouth; feeling hot; heartbeat problems; and muscle tightness. For more information, please see the complete Prescribing Information, including BOXED WARNINGS, and the Medication Guide at www.treximet.com. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. About Pernix Therapeutics To learn more about Pernix Therapeutics, visit www.pernixtx.com. Forward-Looking Statements CONTACT |
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