FDA Will Review Filing to Expand Use of ProAir®
RespiClick in Pediatric Patients with Asthma
JERUSALEM--(BUSINESS WIRE)--Sep. 10, 2015--
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) announced today that
the U.S. Food and Drug Administration (FDA) has accepted for review the
company’s supplemental new drug application (sNDA) for ProAir®
RespiClick (albuterol sulfate) Inhalation Powder for the treatment or
prevention of bronchospasm in patients 4 to 11 years of age with
reversible obstructive airway disease and for the prevention of
exercise-induced bronchospasm (EIB).
ProAir® RespiClick was approved by the FDA in March 2015 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 EIB. ProAir® RespiClick is the only multi-dose,
breath-activated short-acting beta-agonist (SABA) inhaler available to
patients in the U.S. It differs from other currently available rescue
inhalers as it utilizes breath-activated technology that enables
patients to breathe in to receive a measured dose of the medicine,
eliminating the need for hand-breath coordination during inhalation.
“The acceptance of the pediatric filing for ProAir®
RespiClick by the FDA represents an important step forward for Teva in
our mission to better serve patients living with respiratory conditions,
such as asthma and EIB,” said Tushar Shah, MD, Senior Vice President,
Teva Global Respiratory Research and Development. “With millions of
children living with asthma in the United States, it is important to
provide this age group with a new option in rescue inhalers that does
not require hand-breath coordination during inhalation.”
The sNDA for ProAir® RespiClick includes data from Teva’s
pediatric clinical trial program that evaluated the safety and efficacy
of the treatment in children 4 – 11 years of age. The sNDA for ProAir®
RespiClick has been accepted by the FDA for standard review, with FDA
Regulatory Action expected in April 2016.
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. Call your doctor right away if you develop red, itchy bumps on
your skin, swelling beneath your skin or in your throat, rash or
worsening trouble breathing
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.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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