Teva Announces the U.S. Launch of its Generic Version of SOOLANTRA® (ivermectin) Cream, 1% for Once Daily Treatment of Rosacea
June 16 2021 - 7:36AM
Business Wire
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd.(NYSE and TASE: TEVA), today announced the U.S.
launch of its generic version of once daily SOOLANTRA® (ivermectin)
Cream, 1% for the treatment of inflammatory lesions of rosacea.
With nearly 550 generic medicines available, Teva has the
largest portfolio of FDA-approved generic products on the market.
Currently, 1 in 11 generic prescriptions dispensed in the U.S. is
filled with a Teva generic product.
SOOLANTRA® had annual sales of more than $115 million in the
U.S., according to IQVIA data as of April 2021.
About Ivermectin Cream 1%
Ivermectin cream, 1% is a prescription medicine used for the
treatment of inflammatory lesions of rosacea.
IMPORTANT SAFETY INFORMATION
Ivermectin cream, 1% is NOT for oral (by mouth), ophthalmic
(in the eye), or intravaginal (in the vagina) use.
Pregnancy and Lactation: Ivermectin cream, 1% should be
used during pregnancy only if the potential benefit outweighs any
potential risk to the fetus. There is a potential for serious
adverse reactions from ivermectin cream in nursing infants. A
decision should be made with your doctor whether to discontinue
nursing or to discontinue the drug.
Side Effects: Side effects include skin burning sensation
and skin irritation. Talk to your doctor if you experience side
effects and also about possible side effects that could occur. You
may report side effects of prescription drugs to FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
Keep Ivermectin cream out of reach of children.
Please see the full Prescribing Information and Instructions for
Use.
About Teva
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 3,500
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 of our generic version of SOOLANTRA®
(ivermectin) Cream, 1% in the United States, 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:
- the commercial success of our SOOLANTRA®(ivermectin) Cream,
1%;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; consolidation of our customer base and commercial
alliances among our customers; delays in launches of new generic
products; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for
generic versions of significant products; our ability to develop
and commercialize biopharmaceutical products; competition for our
specialty products, including AUSTEDO®, AJOVY® and COPAXONE®; our
ability to achieve expected results from investments in our product
pipeline; our ability to develop and commercialize additional
pharmaceutical products; and the effectiveness of our patents and
other measures to protect our intellectual property rights;
- our substantial indebtedness, which may limit our ability to
incur additional indebtedness, engage in additional transactions or
make new investments, may result in a further downgrade of our
credit ratings; and our inability to raise debt or borrow funds in
amounts or on terms that are favorable to us;
- our business and operations in general, including: uncertainty
regarding the magnitude, duration, and geographic reach of the
COVID-19 pandemic and its impact on our business, financial
condition, operations, cash flows, and liquidity and on the economy
in general; our ability to successfully execute and maintain the
activities and efforts related to the measures we have taken or may
take in response to the COVID-19 pandemic and associated costs
therewith; effectiveness of our optimization efforts; our ability
to attract, hire and retain highly skilled personnel; manufacturing
or quality control problems; interruptions in our supply chain;
disruptions of information technology systems; breaches of our data
security; variations in intellectual property laws; challenges
associated with conducting business globally, including political
or economic instability, major hostilities or terrorism; costs and
delays resulting from the extensive pharmaceutical regulation to
which we are subject or delays in governmental processing time due
to travel and work restrictions caused by the COVID-19 pandemic;
the effects of reforms in healthcare regulation and reductions in
pharmaceutical pricing, reimbursement and coverage; significant
sales to a limited number of customers; our ability to successfully
bid for suitable acquisition targets or licensing opportunities, or
to consummate and integrate acquisitions; and our prospects and
opportunities for growth if we sell assets;
- compliance, regulatory and litigation matters, including:
failure to comply with complex legal and regulatory environments;
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications and our ability to
reach a final resolution of the remaining opioid-related
litigation; scrutiny from competition and pricing authorities
around the world, including our ability to successfully defend
against the U.S. Department of Justice criminal charges of Sherman
Act violations; potential liability for patent infringement;
product liability claims; failure to comply with complex Medicare
and Medicaid reporting and payment obligations; compliance with
anti-corruption sanctions and trade control laws; and environmental
risks;
- other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
significant increases in tax liabilities; and the effect on our
overall effective tax rate of the termination or expiration of
governmental programs or tax benefits, or of a change in our
business;
and other factors discussed in this press release and in our
Annual Report on Form 10-K for the year ended December 31, 2020,
including in the sections captioned "Risk Factors” and “Forward
Looking Statements.” 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 statements.
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IR Contacts United States Kevin C. Mannix (215) 591-8912
Israel Yael Ashman 972 (3) 914-8262 PR Contacts
United States Kelley Dougherty (973) 658-0237 Israel
Yonatan Beker 972 (54) 888 5898
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