JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
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.