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Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of a generic version of Elidel®1
(pimecrolimus) Cream, 1% in the U.S.
Pimecrolimus Cream, 1% is a topical prescription medicine to be used as
second-line therapy for the short-term and non-continuous chronic
treatment of mild to moderate eczema (atopic dermatitis) in
non-immunocompromised adults and children 2 years of age and older who
have failed to respond adequately to other topical prescription
treatments, or when those treatments are not advisable.
Brendan O’Grady, EVP and Head of North America Commercial at Teva said,
“We’re proud to offer another affordable treatment option. This launch
represents an important addition to our generics portfolio and
underscores our commitment to ensuring that patients have more treatment
With over 550 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 seven generic prescriptions
dispensed in the U.S. is filled with a Teva generic product.
Elidel® Cream, 1% had annual sales of approximately $218.4
million in the US, according to IQVIA data as of October 2018.
About Pimecrolimus Cream, 1%
Pimecrolimus Cream, 1% is indicated as second-line therapy for the
short-term and non-continuous chronic treatment of mild to moderate
atopic dermatitis in non-immunocompromised adults and children 2 years
of age and older, who have failed to respond adequately to other topical
prescription treatments, or when those treatments are not advisable.
IMPORTANT SAFETY INFORMATION
WARNING: Long-term Safety of Topical Calcineurin Inhibitors Has Not
Although a causal relationship has not been
established, rare cases of malignancy (e.g., skin and lymphoma) have
been reported in patients treated with topical calcineurin inhibitors,
including Pimecrolimus Cream, 1%.
Continuous long-term use of
topical calcineurin inhibitors, including Pimecrolimus Cream, 1%, in any
age group should be avoided, and application limited to areas of
involvement with atopic dermatitis.
Pimecrolimus Cream, 1% is not
indicated for use in children less than 2 years of age.
Pimecrolimus Cream, 1% is contraindicated in individuals with a history
of hypersensitivity to pimecrolimus or any of the components of the
cream. Pimecrolimus Cream, 1% should not be used in immunocompromised
adults and children, including patients on systemic immunosuppressive
medications. The use of pimecrolimus cream, 1% should be avoided on
malignant or pre-malignant skin conditions. Malignant or pre-malignant
skin conditions, such as cutaneous T-cell lymphoma (CTCL), can present
as dermatitis. Pimecrolimus Cream, 1% should not be used in patients
with Netherton’s Syndrome or other skin diseases where there is the
potential for increased systemic absorption of pimecrolimus. The safety
of Pimecrolimus Cream, 1% has not been established in patients with
Before commencing treatment with Pimecrolimus Cream, 1%, bacterial or
viral infections at treatment sites should be resolved. The use of
Pimecrolimus Cream, 1% may cause local symptoms such as skin burning
(burning sensation, stinging, soreness) or pruritus. During the course
of treatment, it is prudent for patients to minimize or avoid natural or
artificial sunlight exposure, even while Pimecrolimus Cream, 1% is not
on the skin. The potential effects of Pimecrolimus Cream, 1% on skin
response to ultraviolet damage are not known.
In clinical trials, cases of lymphadenopathy were reported while using
Pimecrolimus Cream, 1%. The safety and efficacy of Pimecrolimus Cream,
1% in immunocompromised patients have not been studied. In clinical
trials, the most commonly reported adverse reactions (greater than or
equal to 1%) were application site burning, headache, nasopharyngitis,
cough, influenza, pyrexia and viral infection.
For more information, please see accompanying Full
Prescribing Information, including Boxed Warning. A copy may be
requested from Teva US Medical Information at 888-4-TEVA-USA
(888-838-2872) or firstname.lastname@example.org,
or Teva’s Public Relations or Investor Relations contacts.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global
leader in generic medicines, with innovative treatments in select areas,
including CNS, pain and respiratory. We deliver high-quality generic
products and medicines in nearly every therapeutic area to address unmet
patient needs. We have an established presence in generics, specialty,
OTC and API, building on more than a century-old legacy, with a fully
integrated R&D function, strong operational base and global
infrastructure and scale. We strive to act in a socially and
environmentally responsible way. Headquartered in Israel, with
production and research facilities around the globe, we employ 45,000
professionals, committed to improving the lives of millions of patients.
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 Teva's generic version of Elidel
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, 2017, including in the section captioned “Risk
Factors,” and in our other filings with the U.S. Securities and Exchange
Commission, which are available at
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, future events or otherwise. You
are cautioned not to put undue reliance on these forward-looking
1 ELIDEL® is a registered trademark of Meda Pharma
S.A.R.L. used under license © 2017 Valeant Pharmaceuticals North America
LLC.2 ELIDEL® is a registered trademark of
Meda Pharma S.A.R.L. used under license © 2017 Valeant Pharmaceuticals
North America LLC.
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Source: Teva Pharmaceutical Industries Ltd.