Teva Pharmaceutical Industries Ltd. issued the following announcement on May 10.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced the launch of a generic version of Delzicol®1 (mesalamine) delayed-release capsules, 400 mg, in the U.S.
Mesalamine Delayed-Release Capsules are an aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older, and for the maintenance of remission of ulcerative colitis in adults.
Teva EVP and Head of North America Commercial, Brendan O’Grady said, “Ulcerative colitis is a chronic inflammatory bowel disease and we’re proud to provide another treatment option for patients.”
Mesalamine Delayed-Release Capsules further enhance Teva’s already-comprehensive portfolio of medicines to treat gastrointestinal disorders. 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.
Delzicol® delayed-release capsules have annual sales of approximately $130 million in the U.S., according to IMS data as of February 2019.
About Mesalamine Delayed-Release Capsules
Mesalamine Delayed-Release Capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older and for the maintenance of remission of ulcerative colitis in adults.
Important Safety Information
Mesalamine Delayed-Release Capsules are contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of Mesalamine Delayed-Release Capsules.
Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and renal failure, has been reported in patients taking products that contain mesalamine or are converted to mesalamine. Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis. Hypersensitivity reactions have been reported in patients taking sulfasalazine. Some patients may have a similar reaction to mesalamine or to other compounds that contain or are converted to mesalamine. There have been reports of hepatic failure in patients with preexisting liver disease who have been administered mesalamine.
The most common adverse reactions (≥ 5%) in clinical trials were eructation, abdominal pain, constipation, dizziness, rhinitis, back pain, and rash in adults; and nasopharyngitis, headache, abdominal pain, dizziness, sinusitis, rash, cough, and diarrhea in pediatrics.
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) or druginfo@tevapharm.com, or Teva’s Public Relations or Investor Relations contacts.
Original source can be found here.
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