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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
Delzicol® delayed-release capsules have annual sales of
approximately $130 million in the U.S., according to IMS data as of
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
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 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
, 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
and other factors discussed in our Annual Report on Form 10-K for the
year ended December 31, 2018, including the sections thereof captioned
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 Delzicol® is a registered trademark of Allergan
Pharmaceuticals International Limited.
View source version on businesswire.com:
Kevin C. Mannix(215)
Ran Meir(215) 591-3033
Yonatan Beker972 (54) 888 5898
Source: Teva Pharmaceutical Industries Ltd.