Teva Pharmaceutical Industries (NYSE and TASE: TEVA) today
announced the release of limited doses of the FDA-approved generic
version of EpiPen®1 (epinephrine injection, USP) Auto-Injector, 0.3
mg, in the US. Teva’s generic version of the EpiPen Jr®
(epinephrine injection, USP) Auto-Injector, 0.15 mg, and an
additional supply of Teva’s generic version of the EpiPen®
(epinephrine injection, USP) Auto-Injector, 0.3 mg is expected in
2019. The publically-available Wholesale Acquisition
Cost (WAC)2 for the product is $300.
Brendan O’Grady, EVP and Head of North America Commercial at
Teva said, “We’re pleased to provide access to Epinephrine
Injection (Auto-Injector) for patients who may experience
life-threatening allergic emergencies and we’re fully dedicated
toward ensuring additional supply in 2019.”
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 US. Currently, one in seven generic
prescriptions dispensed in the US is filled with a Teva generic
product.
About EPINEPHRINE Injection
Epinephrine Injection (Auto-Injector) is a prescription medicine
in a disposable, prefilled automatic injection device
(auto-injector) used to treat life-threatening, allergic
emergencies including anaphylaxis in people who are at risk for or
have a history of serious allergic emergencies. Each device
contains a single dose of epinephrine.
Epinephrine Injection (Auto-Injector) is for immediate self (or
caregiver) administration and does not take the place of emergency
medical care. You should get emergency help right away after using
Epinephrine Injection (Auto-Injector).
IMPORTANT SAFETY
INFORMATION
Anaphylaxis can be life-threatening, can happen within minutes,
and can be caused by stinging and biting insects, allergy
injections, foods, medicines, exercise, or unknown causes. Use
Epinephrine Injection (Auto-Injector) right away when you have an
allergic emergency (anaphylaxis). Get emergency medical help
right away. You may need further medical attention. You may
need to use a second Epinephrine Injection (Auto-Injector) if
symptoms continue or recur. Only a healthcare provider should give
additional doses of epinephrine if you need more than 2 injections
for a single anaphylaxis episode.
Epinephrine Injection (Auto-Injector) should only be
injected into the middle of your outer thigh (upper leg) through
clothing if necessary. Do not inject the Epinephrine
Injection (Auto-Injector) into your: veins, buttocks, fingers,
toes, hands, or feet. If you inject a young child with Epinephrine
Injection (Auto-Injector), hold their leg firmly in place before
and during the injection to prevent injuries. If you accidentally
inject Epinephrine Injection (Auto-Injector) into any other part of
your body, go to the nearest emergency room right away. Tell the
healthcare provider where on your body you received the accidental
injection.
Rarely, patients who have used Epinephrine Injection
(Auto-Injector) may develop infections at the injection site within
a few days of an injection. Some of these infections can be
serious. Call your healthcare provider right away if you have any
of the following at an injection site: redness that does not go
away, swelling, tenderness, or the area feels warm to the
touch.
If you have certain medical conditions, or take certain
medicines, your condition may get worse or you may have longer
lasting side effects when you use your Epinephrine Injection
(Auto-Injector). Tell your healthcare provider about all known
allergies, all your medical conditions and all the medicines you
take, especially if you take asthma medicines.
Common side effects of Epinephrine Injection (Auto-Injector)
include: fast, irregular or “pounding” heartbeat; sweating;
headache; weakness; shakiness; paleness; feelings of over
excitement, nervousness or anxiety; dizziness; nausea or vomiting;
and breathing problems. These side effects may go away with rest.
Tell your healthcare provider if you have any side effect that
bothers you or that does not go away.
These are not all the possible side effects of Epinephrine
Injection (Auto-Injector). For more information, ask your
healthcare provider or pharmacist. Call your healthcare provider
for medical advice about side effects. You may report side effects
to FDA at 1-800-FDA-1088.
For more information, please see accompanying Full
Prescribing Information.
A copy may be requested from Teva US Medical Information at
888-4-TEVA-USA (888-838-2872) or druginfo@tevapharm.com, or Teva’s
Public Relations or Investor Relations contacts.
About Teva
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 epinephrine injection USP, 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 uncertainty of the commercial
success of our generic version of epinephrine injection USP,
including our ability to provide additional supply of the
product;
- our ability to successfully compete in
the marketplace, including: that we are substantially dependent on
our generic products; competition for our specialty products,
especially COPAXONE®, our leading medicine, which faces competition
from existing and potential additional generic versions and
orally-administered alternatives; competition from companies with
greater resources and capabilities; efforts of pharmaceutical
companies to limit the use of generics including through
legislation and regulations; consolidation of our customer base and
commercial alliances among our customers; the increase in the
number of competitors targeting generic opportunities and seeking
U.S. market exclusivity for generic versions of significant
products; price erosion relating to our products, both from
competing products and increased regulation; delays in launches of
new products and our ability to achieve expected results from
investments in our product pipeline; our ability to take advantage
of high-value opportunities; the difficulty and expense of
obtaining licenses to proprietary technologies; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
- our substantially increased
indebtedness and significantly decreased cash on hand, which may
limit our ability to incur additional indebtedness, engage in
additional transactions or make new investments, and 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: failure to effectively execute the restructuring plan
announced in December 2017; uncertainties related to, and failure
to achieve, the potential benefits and success of our new senior
management team and organizational structure; harm to our pipeline
of future products due to the ongoing review of our R&D
programs; our ability to develop and commercialize additional
pharmaceutical products; potential additional adverse consequences
following our resolution with the U.S. government of our FCPA
investigation; compliance with sanctions and other trade control
laws; manufacturing or quality control problems, which may damage
our reputation for quality production and require costly
remediation; interruptions in our supply chain; disruptions of our
or third party information technology systems or breaches of our
data security; the failure to recruit or retain key personnel;
variations in intellectual property laws that may adversely affect
our ability to manufacture our products; challenges associated with
conducting business globally, including adverse effects of
political or economic instability, major hostilities or terrorism;
significant sales to a limited number of customers in our U.S.
market; 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: costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; governmental investigations
into sales and marketing practices; potential liability for patent
infringement; product liability claims; increased government
scrutiny of our patent settlement agreements; failure to comply
with complex Medicare and Medicaid reporting and
payment obligations; 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 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
www.sec.gov and www.tevapharm.com. 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.
1 EpiPen® and EpiPen Jr® are registered trademarks of
Mylan®.
2 Teva does not set the price that a pharmacy charges for a
particular drug and does not has visibility or control into the
price of the drug in the marketplace.
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IR ContactsUnited StatesKevin C. Mannix(215)
591-8912orIsraelRan Meir972 (3) 9267516orPR
ContactsUnited StatesKelley Dougherty(973)
658-0237orElizabeth DeLuca(267) 468-4329orIsraelYonatan
Beker972 (54) 888 5898
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