Pharmaceutical

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved ProAir RespiClick® (albuterol sulfate) Inhalation Powder for the treatment or prevention of bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB). …

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) announced
today that the U.S. Food and Drug Administration (FDA) has approved
ProAir RespiClick® (albuterol sulfate) Inhalation Powder for
the treatment or prevention of bronchospasm in children 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 for use in
patients 12 years of age and older in March 2015 and remains the only
breath-activated, multi-dose, dry powder, short-acting beta-agonist
(SABA) inhaler available in the U.S.
“The prevalence of childhood asthma in the U.S. is high, at more than
six million patients, and that number continues to rise,” said Dr. Erwin
Gelfand, Chairman, Department of Pediatrics at National Jewish Health.
“For this young population of asthma patients, learning to use inhalers
properly can be quite challenging. Thus, the pediatric indication for
ProAirRespiClick® is important as it represents a
new rescue inhaler option for younger patients that eliminates the need
for hand-breath coordination during inhalation and was designed to be
used without a spacer.”
The pediatric approval of ProAir RespiClick® comes after the
FDA’s review of data from Teva’s Phase III clinical trial program that
evaluated the safety and efficacy of the treatment in patients as young
as four years of age, living with asthma. The data demonstrated that
treatment with ProAir RespiClick® resulted in significantly
greater improvement in forced expiratory volume (FEV1)
compared to placebo. The most common adverse events associated with
treatment with ProAir RespiClick® included upper respiratory
infections, mouth and throat pain and vomiting.
“We are very pleased with the FDA’s decision to expand the indication of
ProAir RespiClick® for the treatment of patients as young as
four years of age,” said Tushar Shah, MD, Senior Vice President, Teva
Global Respiratory Research and Development. “The availability of this
treatment option for younger patients is a demonstration of Teva’s
commitment to optimizing respiratory therapies through the development
of new delivery systems that help address needs in the marketplace.”
Approved Uses
ProAir RespiClick® (albuterol sulfate) Inhalation Powder is
indicated in patients 4 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 ProAirRespiClick® (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 12 years of age and older taking
    ProAir RespiClick® include back pain, body aches and pains,
    upset stomach, sinus headache, and urinary tract infection
  • Common side effects in patients 4 to 11 years of age taking ProAir
    RespiClick® include upper respiratory infections, mouth and
    throat pain, and vomiting
  • Tell your healthcare provider if you have any side effect that bothers
    you or that does not go away
  • These are not all of the possible side effects of ProAir RespiClick®.
    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

Please
click here for Full Prescribing Information

About Teva Respiratory
Teva Respiratory develops and delivers high-quality treatment options
for respiratory conditions, including asthma, COPD and allergic
rhinitis. The Teva Respiratory portfolio is centered on optimizing
respiratory treatment for patients and healthcare providers through the
development of novel delivery systems and therapies that help address
unmet needs. The company’s respiratory pipeline and clinical trial
program are based on drug molecules delivered in proprietary dry powder
formulations and breath-actuated device technologies, as well as a
targeted biologic treatment for severe asthma. Through research and
clinical development, Teva Respiratory continually works to expand,
strengthen and build upon its treatment portfolio to positively impact
the lives of the millions of patients living with respiratory disease.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by 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 2015 amounted to $19.7 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 specialty products, especially Copaxone® (which
faces competition from orally-administered alternatives and a generic
version); our ability to consummate the acquisition of Allergan plc’s
worldwide generic pharmaceuticals business (“Actavis Generics”) and to
realize the anticipated benefits of such acquisition (and the timing of
realizing such benefits); the fact that following the consummation of
the Actavis Generics acquisition, we will be dependent to a much larger
extent than previously on our generic pharmaceutical business; potential
restrictions on our ability to engage in additional transactions or
incur additional indebtedness as a result of the substantial amount of
debt we will incur to finance the Actavis Generics acquisition; the fact
that for a period of time following the consummation of the Actavis
Generics acquisition, we will have significantly less cash on hand than
previously, which could adversely affect our ability to grow; 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
investments in our pipeline of specialty and other products; 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; competition for our generic products, both
from other pharmaceutical companies and as a result of increased
governmental pricing pressures; 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 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, 2015 and in our other filings with the U.S. Securities and Exchange
Commission (the “SEC”). 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, whether as a
result of new information, future events or otherwise.

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