Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the launch of a generic version of VESIcare (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.
Source: Company Press Release