ProAir® HFA (albuterol sulfate) with Dose Counter Now Available to Patients

  ProAir® HFA (albuterol sulfate) with Dose Counter Now Available to Patients

Business Wire

NORTH WALES, Pa. -- January 3, 2013

Teva Respiratory announced today the availability of ProAir^® HFA with dose
counter for use 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 (EIB). The availability of
ProAir^® HFA with dose counter supports the U.S. Food and Drug
Administration’s (FDA) recommendations for such mechanisms, as a means for
patients and caregivers to track the number of doses remaining in their
inhaler, thus reducing the risk of utilizing an inhaler that no longer
contains the medication required at the onset of asthma symptoms.

“As the market leader in quick-relief inhalers, we are pleased to offer
patients the latest in product enhancements designed to help better manage
their condition,” said Tushar Shah, MD, Senior Vice President, Teva Global
Respiratory Research and Development. “This milestone in the ProAir^® brand
shows our continued efforts to deliver the best treatment solutions that meet
patients’ or their caregivers’ needs.”

On March 7, 2012, the FDA approved ProAir^® HFA with a dose counter. Teva
spent the months following FDA approval manufacturing a substantial inventory
of ProAir^® HFA with dose counter, ensuring a full conversion of supply and
product availability to patients.

According to the FDA, inhalers without dose counters can present an issue for
patients or caregivers as they can be left to guess how many doses remain.
Without a dose counter, patients or caregivers may either throw away an
inhaler that hasn’t been fully utilized or use an inhaler beyond the
recommended number of doses and risk receiving the incorrect amount of
medication or no medication at all.

“Symptoms of asthma and COPD are unpredictable. It’s critical that patients
know that their quick acting inhaler is dispensing properly and has an
adequate number of doses left,” said Dr. John Given, ProAir^® HFA with dose
counter clinical trial investigator and respiratory specialist at The Allergy,
Respiratory and Sleep Center in Canton, OH. “Using an inhaler without
sufficient dosage is potentially dangerous because a full dose plays a vital
role in treatment. That's why a reliable and precise dose counter like the one
incorporated into the new ProAir^® HFA is crucial for effective and safe
treatment of the symptoms of asthma and COPD.”

ProAir^® HFA was first approved by the FDA in October 2004 for treatment or
prevention of bronchospasm with reversible obstructive airway disease in
adults and children 12 years of age and older. In September 2008, the FDA
expanded the indication for use in patients as young as age 4.

About Asthma

Asthma is a chronic inflammatory disorder of the large and small airways that
may cause recurrent episodes of wheezing, breathlessness, chest tightness, and
coughing.Without appropriate treatment, asthma symptoms may become more
severe and result in an asthma attack, which can lead to hospitalization and
even death.

About ProAir^® HFA with Dose Counter

ProAir^® HFA (albuterol sulfate) Inhalation Aerosol with dose counter 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. In March 2012, the U.S. Food and
Drug Administration approved the addition of the dose counter, an innovation
designed to help patients, as well as their caregivers, keep track of the
number of doses remaining in the inhaler.

ProAir^® HFA with dose counter supports the FDA’s recommendations for such
mechanisms, as a means to track the number of doses remaining. Dose counters
reduce the risk of utilizing an inhaler that no longer contains the medication
required.

The safety and efficacy of ProAir^® HFA was determined through clinical trials
comparing it to a marketed active comparator albuterol HFA inhaler and placebo
HFA aerosol. In clinical trials of adults and children with asthma, ProAir^®
HFA produced bronchodilator responses greater than those observed with a
matched placebo HFA inhalation aerosol and comparable safety and efficacy to
the active comparator albuterol HFA inhaler.

Important Safety Information

If your symptoms become significantly worse when you use ProAir^® HFA, contact
your doctor immediately. This may indicate either a worsening of your asthma
or a reaction to the medication, which may rarely occur with the first use of
a new canister of ProAir^® HFA. Either of these could be life-threatening.

What to tell your doctor before using ProAir^® HFA: If you have a heart,
blood, or seizure disorder, high blood pressure, diabetes, or an overactive
thyroid, be sure to tell your doctor. Also make sure your doctor knows all
medications you are taking, especially heart medications and drugs that treat
depression, because some medications may interfere with how well your asthma
medications work. Do not exceed the recommended dose.

Side effects associated with ProAir^® HFA included headache, rapid heartbeat,
pain, dizziness, and irritation of the throat and nose.

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 see full prescribing information at
http://www.proairhfa.com/pdf/ProAirPrescribingInformation.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 specialty pharmaceuticals and active pharmaceutical ingredients.
Headquartered in Israel, Teva is a world leading generic drug maker, with a
global product portfolio of more than 1,300 molecules and a direct presence in
about 60 countries. Teva's branded businesses focus on CNS, oncology, pain,
respiratory and women's health therapeutic areas. Teva currently employs
approximately 46,000 people around the world and reached $18.3 billion in net
revenues in 2011.

Teva’s Safe Harbor Statement under the U.S. Private Securities Litigation
Reform Act of 1995:

The following discussion and analysis contains forward-looking statements,
which express the current beliefs and expectations of management. Such
statements 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 from
the introduction of competing generic equivalents and due to increased
governmental pricing pressures, the effects of competition on sales of our
innovative medicines, especially Copaxone^® (including competition from
innovative orally-administered alternatives as well as from potential generic
equivalents), potential liability for sales of generic medicines prior to a
final resolution of outstanding patent litigation, including that relating to
our generic version of Protonix^®, the extent to which we may obtain U.S.
market exclusivity for certain of our new generic medicines, the extent to
which any manufacturing or quality control problems damage our reputation for
high quality production and require costly remediation, our ability to
identify, consummate and successfully integrate acquisitions (including the
acquisition of Cephalon), our ability to achieve expected results through our
innovative R&D efforts, dependence on the effectiveness of our patents and
other protections for innovative medicines, intense competition in our
specialty pharmaceutical businesses, uncertainties surrounding the legislative
and regulatory pathway for the registration and approval of
biotechnology-based medicines, our potential exposure to product liability
claims to the extent not covered by insurance, any failures to comply with the
complex Medicare and Medicaid reporting and payment obligations, our exposure
to currency fluctuations and restrictions as well as credit risks, the effects
of reforms in healthcare regulation and pharmaceutical pricing and
reimbursement, adverse effects of political instability and adverse economic
conditions, major hostilities or acts of terrorism on our significant
worldwide operations, increased government scrutiny in both the U.S. and
Europe of our agreements with brand companies, interruptions in our supply
chain or problems with our information technology systems that adversely
affect our complex manufacturing processes, the impact of continuing
consolidation of our distributors and customers, the difficulty of complying
with U.S. Food and Drug Administration, European Medicines Agency and other
regulatory authority requirements, potentially significant impairments of
intangible assets and goodwill, potential increases in tax liabilities
resulting from challenges to our intercompany arrangements, the termination or
expiration of governmental programs or tax benefits, any failure to retain key
personnel or to attract additional executive and managerial talent,
environmental risks, and other factors that are discussed in our Annual Report
on Form 20-F for the year ended December 31, 2011 and in our other filings
with the U.S. Securities and Exchange Commission (“SEC”). Forward-looking
statements speak only as of the date on which they are made, and we undertake
no obligation to update any forward-looking statements or other information
contained in this report, whether as a result of new information, future
events or otherwise.

Contact:

Teva Pharmaceuticals Ltd
Shannon Oates-Rivera, 610-318-0512
shannon.oates-rivera@tevapharm.com
 
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