All Teva Respiratory Brands in the United States Will Soon Be
Available With a Dose Counter
JERUSALEM--(BUSINESS WIRE)--May 23, 2014--
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announced that
the U.S. Food and Drug Administration (FDA) has approved the use of QVAR®
(beclomethasone dipropionate HFA) with a dose counter for the ongoing
treatment of asthma as a preventative therapy in patients five years of
age and older. The dose counter is designed to help asthma patients, as
well as their caregivers, keep track of the number of doses remaining in
the canister. The new product will be commercially available later this
year.
“Bringing QVAR® with a dose counter to market reaffirms
Teva’s commitment to addressing unmet needs by providing high-quality
and innovative solutions to patients,” said Tushar Shah, MD, Senior Vice
President, Teva Global Respiratory Research and Development. “Adding to
our rich heritage within the respiratory space, we are pleased that all
Teva Respiratory brands in the U.S. will soon include a dose counter,
which will help patients and caregivers track how many doses of their
medication remain.”
QVAR® is an inhaled corticosteroid (ICS) recommended as a
twice-daily treatment for long-term asthma control. Adherence to daily
control medications, like QVAR®, is important because when
asthma is well controlled, fewer asthma attacks may occur.
“Inhaled corticosteroid treatments, like QVAR®, should be
taken daily by patients with mild-to-moderate persistent asthma to
reduce inflammation in the airways and prevent asthma symptoms,” said
Dr. Gene Colice, Director of Pulmonary, Critical Care and Respiratory
Services at Washington Hospital Center in Washington, DC. “By using QVAR®
with a dose counter, patients will be able to easily track their daily
doses of medication and help ensure that they are taking QVAR®
as prescribed by their doctor.”
Over the last decade, the Asthma and Allergy Network Mothers of
Asthmatics (AANMA) has conducted several surveys that found patients
with asthma do not have a reliable means of monitoring the contents of
their metered-dose inhalers (MDIs) resulting in serious problems for
many patients. Thus, AANMA recommends that all manufacturers should
include dose counters as a standard feature of every metered-dose
inhaler (MDI).
In 2003, the FDA issued guidance recommending that MDIs should have a
clear indication of when an MDI is approaching the end of its
recommended number of actuations, as well as when it has reached or
exceeded that number. QVAR® with a dose counter clearly
displays the remaining doses of medication in the inhaler.
About QVAR®
QVAR® is indicated in the maintenance treatment of asthma as
prophylactic therapy in patients 5 years of age or older. QVAR®
is also indicated for asthma patients who require systemic
corticosteroid administration, where adding QVAR® may reduce
or eliminate the need for systemic corticosteroids.
Important Safety Information
QVAR® does not replace quick-relief inhalers for sudden
symptoms.
CAUTION: If you are stopping or switching from an oral corticosteroid to
QVAR®, follow your doctor's instructions to avoid health
risks.
Inhaled corticosteroids may cause a reduction in growth rate, so
children taking QVAR® should have their growth checked
regularly. The long-term effect on final adult growth is unknown.
Do not stop taking QVAR® abruptly without talking to your
doctor.
In clinical studies, common side effects included headache and sore
throat. These are not all of the possible side effects of QVAR®.
For more information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.
For full Prescribing Information, please click here:
http://www.qvar.com/library/docs/prescribing-information.pdf
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic
drugs as well as innovative and specialty pharmaceuticals and active
pharmaceutical ingredients. Headquartered in Israel, Teva is the world's
leading generic drug maker, with a global product portfolio of more than
1,000 molecules and a direct presence in approximately 60 countries.
Teva's Specialty Medicines businesses focus on CNS, respiratory,
oncology, pain, and women's health therapeutic areas as well as
biologics. Teva currently employs approximately 45,000 people around the
world and reached $20.3 billion in net revenues in 2013.
Safe Harbor Statement under the U.S. Private Securities Litigation
Reform Act of 1995:
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our innovative products, especially COPAXONE®
(including competition from orally-administered alternatives, as well as
from potential purported generic equivalents); the possibility of
material fines, penalties and other sanctions and other adverse
consequences arising out of our ongoing FCPA investigations and related
matters; our ability to achieve expected results from the research and
development efforts invested in our pipeline of specialty and other
products; our ability to reduce operating expenses to the extent and
during the timeframe intended by our cost reduction program; our ability
to identify and successfully bid for suitable acquisition targets or
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the extent to which any manufacturing or quality control problems damage
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our potential exposure to product liability claims that are not covered
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of our patent settlement agreements; our exposure to currency
fluctuations and restrictions as well as credit risks; the effectiveness
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the intellectual property rights of our specialty medicines; the
effects of reforms in healthcare regulation and pharmaceutical pricing,
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marketing practices, particularly for our specialty pharmaceutical
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effects of increased leverage and our resulting reliance on access to
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supply chain or problems with internal or third-party information
technology systems that adversely affect our complex manufacturing
processes; significant disruptions of our information technology systems
or breaches of our data security; competition for our generic
products, both from other pharmaceutical companies and as a result of
increased governmental pricing pressures; competition for our specialty
pharmaceutical businesses from companies with greater resources and
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for significant new generic products; potential liability in the U.S.,
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resolution of outstanding patent litigation; any failures to comply with
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impact of continuing consolidation of our distributors and customers;
significant impairment charges relating to intangible assets and
goodwill; potentially significant increases in tax liabilities; 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; variations in patent laws that may adversely affect our
ability to manufacture our products in the most efficient manner;
environmental risks; and other factors that are discussed in our Annual
Report on Form 20-F for the year ended December 31, 2013 and in our
other filings with the U.S. Securities and Exchange Commission.
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
statement, whether as a result of new information, future events or
otherwise.
Source: Teva Pharmaceutical Industries Ltd.
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