Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the launch of a generic version of Ranexa®1 (ranolazine) Extended-Release Tablets, 500 mg and 1000 mg, in the U.S.
Ranolazine Extended-Release Tablets are indicated for the treatment of chronic angina.
“We’re pleased to add to our portfolio of generic medicines that offer another treatment option for people living with chronic conditions like angina,” said Brendan O’Grady, EVP and Head of North America Commercial.
With nearly 500 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in eight generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
Ranolazine Extended-Release Tablets has annual sales of nearly $938 million in the U.S., according to IQVIA data as of February 2019.
About Ranolazine Extended-Release Tablets
Ranolazine Extended-Release Tablets are indicated for the treatment of chronic angina. Ranolazine Extended-Release Tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.
IMPORTANT SAFETY INFORMATION
Ranolazine Extended-Release Tablets are contraindicated in patients taking strong inhibitors of CYP3A; patients taking inducers of CYP3A; and patients with liver cirrhosis.
Ranolazine blocks IKr and prolongs the QTc interval in a dose-related manner. Clinical experience in an acute coronary syndrome population did not show an increased risk of proarrhythmia or sudden death. However, there is little experience with high doses (greater than 1,000 mg twice daily) or exposure, other QT-prolonging drugs, potassium channel variants resulting in a long QT interval, in patients with a family history of (or congenital) long QT syndrome, or in patients with known acquired QT interval prolongation. Acute renal failure has been observed in some patients with severe renal impairment (creatinine clearance less than 30 mL/min) while taking Ranolazine Extended-Release Tablets.
In controlled clinical trials of angina patients, the most frequently reported treatment-emergent adverse reactions (greater than 4% and more common on Ranolazine Extended-Release Tablets than on placebo) were dizziness, headache, constipation, and nausea. Dizziness may be dose-related.
For more information, please see accompanying Full Prescribing Information. A copy may be requested from Teva U.S. Medical Information at 888-TEVA-USA (888-838-2872), email@example.com, or Teva’s Public Relations or Investor Relations contacts.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 35,000 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com
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 the generic version of Ranexa®, 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 10-K for the year ended December 31, 2018, including the sections thereof captioned "Risk Factors." 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.
1 Ranexa® is a registered trademark of Gilead Sciences, Inc.
Kevin C. Mannix
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