Teva Announces FDA Approval of ProAir® RespiClick
01 Avril 2015 - 2:00PM
Business Wire
First Breath-Actuated Dry-Powder Short-Acting
Beta-Agonist (SABA) Inhaler to be Approved by the FDA
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announced
that the U.S. Food and Drug Administration (FDA) has approved
ProAir® RespiClick (albuterol sulfate) inhalation powder, a
breath-actuated, multi-dose, dry-powder, short-acting beta-agonist
(SABA) inhaler for the treatment or prevention of bronchospasm in
patients 12 years of age and older with reversible obstructive
airway disease; and for the prevention of exercise-induced
bronchospasm (EIB) in patients 12 years of age and older. It is
expected to become commercially available to patients during the
second quarter of 2015.
“ProAir® RespiClick is the first and only breath-actuated,
dry-powder rescue inhaler to be approved by the FDA for the
treatment of acute asthma symptoms,” said Dr. David I. Bernstein of
the University of Cincinnati College of Medicine, Division of
Immunology, Allergy and Rheumatology. “The approval of ProAir®
RespiClick is significant as it eliminates the need for hand-breath
coordination during inhalation.”
The approval was based on a comprehensive clinical development
program consisting of eight clinical trials designed to evaluate
the safety and efficacy of ProAir® RespiClick in adults and
adolescents (12 years of age and older) with asthma and EIB.
Clinical trial results showed that ProAir® RespiClick was both safe
and effective with adverse events consistent with those seen with
previous albuterol inhalers. The most common adverse events in
greater than one percent of patients treated with ProAir®
RespiClick, compared to placebo, were back pain, body aches and
pains, upset stomach, sinus headache, and urinary tract
infection.
"Teva is committed to optimizing respiratory therapies through
the development of new delivery systems that address needs in the
marketplace,” said Tushar Shah, MD, Senior Vice President, Teva
Global Respiratory Research and Development. “The approval of
ProAir® RespiClick is an important step forward in the progress of
Teva’s respiratory portfolio as it represents the first U.S.
approval of our core, breath-actuated, dry-powder delivery device
platform which we believe will bring additional benefit to
patients.”
Approved Uses
ProAir® RespiClick (albuterol sulfate) Inhalation Powder is
indicated in patients 12 years of age and older for the treatment
or prevention of bronchospasm with reversible obstructive airway
disease and for the prevention of exercise-induced
bronchospasm.
Important Safety Information
- Do not use ProAir® RespiClick
(albuterol sulfate) Inhalation Powder if you are allergic to
albuterol sulfate, lactose, or milk proteins. Report any red, itchy
bumps on your skin, swelling around the lips or eyes, or rash to
your healthcare professional.
- If your symptoms become significantly
worse when you use ProAir® RespiClick, seek medical attention
immediately. This may indicate either a worsening of your asthma or
a reaction to the medication. Either of these could be
life-threatening.
- Do not increase your dose or take extra
doses of ProAir® RespiClick without first talking to your
healthcare professional.
- Before using ProAir® RespiClick, be
sure to tell your healthcare professional if you have a heart,
blood, thyroid or seizure disorder, high blood pressure, diabetes,
are pregnant or planning to become pregnant, or are breastfeeding
or planning to breastfeed.
- ProAir® RespiClick can cause
significant heart-related side effects, such as an increase in
pulse, blood pressure and/or related symptoms. If you have a heart
condition, your healthcare professional will determine if ProAir®
RespiClick is right for you.
- Make sure your healthcare professional
knows all the medicines you are taking – especially other inhaled
medicines, other asthma medicines, heart and blood pressure
medicines and drugs that treat depression – because some medicines
may interfere with how well your asthma medicines work.
- Common side effects in patients taking
ProAir® RespiClick include back pain, body aches and pains, upset
stomach, sinus headache, and urinary tract infection.
Please click here for Full Prescribing Information
About Asthma
Asthma is a chronic (long-term) disease of inflammation of both
the large and small airways of the lungs, characterized by symptoms
of wheezing and coughing. Asthma causes recurring periods of
wheezing (a whistling sound when you breathe), chest tightness,
shortness of breath and coughing that often occurs at night or
early in the morning. Without appropriate treatment, asthma
symptoms may become more severe and result in an asthma attack,
which can lead to hospitalization and even death.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to millions of patients every
day. Headquartered in Israel, Teva is the world’s largest generic
medicines producer, leveraging its portfolio of more than 1,000
molecules to produce a wide range of generic products in nearly
every therapeutic area. In specialty medicines, Teva has a
world-leading position in innovative treatments for disorders of
the central nervous system, including pain, as well as a strong
portfolio of respiratory products. Teva integrates its generics and
specialty capabilities in its global research and development
division to create new ways of addressing unmet patient needs by
combining drug development capabilities with devices, services and
technologies. Teva's net revenues in 2014 amounted to $20.3
billion. For more information, visit www.tevapharm.com.
Teva's 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) and our ability to migrate users to
our 40 mg/mL version; 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
licensing opportunities, or to consummate and integrate
acquisitions; the extent to which any manufacturing or quality
control problems damage our reputation for quality production and
require costly remediation; increased government scrutiny in both
the U.S. and Europe of our patent settlement agreements; our
exposure to currency fluctuations and restrictions as well as
credit risks; the effectiveness of our patents, confidentiality
agreements and other measures to protect the intellectual property
rights of our specialty medicines; the effects of reforms in
healthcare regulation and pharmaceutical pricing, reimbursement and
coverage; governmental investigations into sales and marketing
practices, particularly for our specialty pharmaceutical products;
adverse effects of political or economic instability, major
hostilities or acts of terrorism on our significant worldwide
operations; interruptions in our 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
capabilities; the impact of continuing consolidation of our
distributors and customers; decreased opportunities to obtain U.S.
market exclusivity for significant new generic products; potential
liability in the U.S., Europe and other markets for sales of
generic products prior to a final resolution of outstanding patent
litigation; our potential exposure to product liability claims that
are not covered by insurance; any failure to recruit or retain key
personnel, or to attract additional executive and managerial
talent; any failures to comply with complex Medicare and Medicaid
reporting and payment obligations; significant impairment charges
relating to intangible assets, goodwill and property, plant and
equipment; the effects of increased leverage and our resulting
reliance on access to the capital markets; 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, 2014 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.
Teva Pharmaceutical Industries Ltd.IR:Kevin C. Mannix,
215-591-8912United StatesorRan Meir, 215-591-3033United
StatesorTomer Amitai, 972 (3) 926-7656IsraelorPR:Iris
Beck Codner, 972 (3) 926-7687IsraelorDenise Bradley,
215-591-8974United StatesorNancy Leone, 215-284-0213United
States
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