Teva Announces FDA Approval of ProAir RespiClick® (albuterol sulfate) Inhalation Powder for Pediatric Asthma Patients Ages 4 to 11

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
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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
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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
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result of new information, future events or otherwise.