Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the launch of a generic version of VESIcare ®1 (solifenacin succinate) Tablets, 5 mg and 10 mg, in the U.S.
Solifenacin Succinate Tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Overactive bladder (OAB) is most often characterized by a strong sudden urge to urinate that is difficult to control.
“About 33 million Americans have overactive bladder.2 We’re proud to offer another treatment option for this common condition,” 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.
VESIcare® Tablets have annual sales of more than $955 million in the U.S., according to IQVIA data as of February 2019.
About Solifenacin Succinate Tablets
Solifenacin Succinate Tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
IMPORTANT SAFETY INFORMATION
Solifenacin Succinate Tablets are contraindicated in patients with urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, and in patients who have demonstrated hypersensitivity to the drug.
Angioedema of the face, lips, tongue, and/or larynx have been reported with solifenacin. Angioedema associated with upper airway swelling may be life threatening. Anaphylactic reactions have been reported rarely in patients treated with solifenacin succinate. Solifenacin Succinate Tablets should not be used in patients with a known or suspected hypersensitivity to solifenacin succinate.
Solifenacin succinate should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. Solifenacin succinate should be used with caution in patients with decreased gastrointestinal motility. Solifenacin succinate is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported, including headache, confusion, hallucinations and somnolence. Solifenacin succinate should be used with caution in patients being treated for narrow-angle glaucoma.
Solifenacin succinate should be used with caution in patients with hepatic or renal impairment. Doses of solifenacin succinate greater than 5 mg are not recommended in patients with moderate hepatic impairment or severe renal impairment. Solifenacin succinate is not recommended for patients with severe hepatic impairment. Solifenacin succinate should be used with caution in patients with a known history of QT prolongation or patients who are taking medications known to prolong the QT interval.
In clinical trials, the most common adverse reactions (> 4% and > placebo) were dry mouth, and constipation at both 5 mg and 10 mg doses; and urinary tract infection, and blurred vision at the 10 mg dose.
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), firstname.lastname@example.org, 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 VESIcare ® , 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 VESIcare® is a registered trademark of Astellas
2 Urology Care Foundation: https://www.urologyhealth.org/urologic-conditions/overactive-bladder-(oab)
Kevin C. Mannix
972 (3) 926-7516
972 (54) 888 5898