» News: Teva's ProAir(R) HFA, the Market Leading Albuterol Inhaler …

News: Teva's ProAir(R) HFA, the Market Leading Albuterol Inhaler …

Teva Pharmaceutical Industries Ltd. today announced that the U.S.
Food and Drug Administration (FDA) has approved ProAir(R) HFA
(albuterol sulfate) Inhalation Aerosol for use in patients as young as
4 years of age. Previously, ProAir HFA had been indicated for use in
patients aged 12 and older.

In clinical studies, ProAir HFA, the market leading albuterol
sulfate inhaler,(1) exhibited significant bronchodilator efficacy in
pediatric asthmatics aged 4 to 11 years. ProAir HFA provides
physicians with a treatment option to help relieve children’s asthma
symptoms as they occur wherever they occur, (2) which is especially
important as children return to school. With asthma affecting more
than one child in every 20 in the United States,(3) studies show that
asthma emergency room and hospitalization rates spike in September.(4)

For environmental reasons, the FDA and U.S. Environmental
Protection Agency (EPA)(5) have mandated the transition from
chlorofluorocarbon (CFC)-based albuterol inhalers to HFA albuterol
inhalers by the end of this year. “Teva is committed to ensuring a
smooth HFA transition and also to providing support for patients using
ProAir HFA,” said Mark Salyer, General Manager, Teva Specialty
Pharmaceuticals.

Teva has been providing doctors and patients with a variety of
educational and cost saving tools to help educate and increase access
to ProAir. Doctors, parents and patients can access this information
at www.ProAirHFA.com and www.Switch2HFA.com.

About Pediatric Asthma

Asthma is a chronic disorder characterized by inflammation of the
air passages and spasm of the muscles around those air passages, both
of which result in the narrowing of the airways that transport air
into the lungs.(6) Asthma symptoms, such as coughing, wheezing, chest
tightness and shortness of breath, can occur and can impact multiple
aspects of patients’ lives.(6) Asthma is the most common chronic
condition among children,(7) currently affecting an estimated 6.8
million children under 18 years of age, 4.1 million of whom suffered
from an asthma attack or episode in 2006.(8) Asthma is also
responsible for almost 3 million physician visits and 200,000
hospitalizations among children each year in the United States.(3) It
also is the third leading cause of hospitalization among children.(3)

About Teva

Teva Specialty Pharmaceuticals-USA is the U.S.-based respiratory
division of Teva Pharmaceutical Industries Ltd. Teva Pharmaceutical
Industries Ltd., headquartered in Israel, is among the top 20
pharmaceutical companies in the world and is the leading generic
pharmaceutical company. The company develops, manufactures and markets
generic and innovative human pharmaceuticals and active pharmaceutical
ingredients. Over 80 percent of Teva’s sales are in North America and
Europe.

See additional important information at www.ProAirHFA.com or
www.Switch2HFA.com. For hard copy releases, please see enclosed full
prescribing information.

ProAir(R) HFA (albuterol sulfate) Inhalation Aerosol 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

If your symptoms become significantly worse when you use ProAir(R)
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(R) HFA.
Either of these could be life-threatening.

What to tell your doctor before using ProAir(R) 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(R) HFA included headache,
rapid heart beat, 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.

REFERENCES:

1. IMS Health National Prescription Audit. Total Rx Data. July
2008.

2. ProAir(R) HFA Package Insert, 2008.

3. “Asthma Facts and Figures.” Asthma and Allergy Foundation of
America, 2005. http://www.aafa.org/display.cfm?id=8&sub=42

4. Johnston, NW et al. The September Epidemic of Asthma
Hospitalization: School Children as Disease Vectors. Journal of
Allergy and Clinical Immunology. March 2006. Vol. 117(3); 557-562.

5. U.S. Food and Drug Administration. Questions and answers on
final rule of albuterol MDI’s. Available at:
http://www.fda.gov/cder/mdi/mdifaqs.htm. Accessed May 2008.

6. “What is Asthma?” National Heart Lung and Blood Institute, May
2006.
http://www.nhlbi.nih.gov/health/dci/Diseases/Asthma/Asthma_WhatIs.html

7. “Chronic Conditions: A Challenge for the 21st Century,”
National Academy on an Aging Society, 2000.

8. Centers for Disease Control and Prevention: National Center for
Health Statistics, National Health Interview Survey Raw Data, 2006.
Analysis by the American Lung Association Research and Program
Services Division using SPSS and SUDAAN software. Available at:
http://www.lungusa.org/site/c.dvLUK9O0E/b.4061173/apps/s/
content.asp?ct=3227479 (Due to its length, this URL may need to be
copied/pasted into your Internet browser’s address field. Remove the
extra space if one exists.) Accessed September 16, 2008.

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

This release contains forward-looking statements, which express
the current beliefs and expectations of management. Such statements
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 successfully develop and commercialize additional
pharmaceutical products, the introduction of competing generic
equivalents, the extent to which we may obtain U.S. market exclusivity
for certain of our new generic products and regulatory changes that
may prevent us from utilizing exclusivity periods, competition from
brand-name companies that are under increased pressure to counter
generic products, or competitors that seek to delay the introduction
of generic products, the impact of consolidation of our distributors
and customers, potential liability for sales of generic products prior
to a final resolution of outstanding patent litigation, including that
relating to the generic versions of Allegra(R) , Neurontin(R),
Lotrel(R) and Protonix(R), the effects of competition on our
innovative products, especially Copaxone(R) sales, the impact of
pharmaceutical industry regulation and pending legislation that could
affect the pharmaceutical industry, the difficulty of predicting U.S.
Food and Drug Administration, European Medicines Agency and other
regulatory authority approvals, the regulatory environment and changes
in the health policies and structures of various countries, our
ability to achieve expected results through our innovative R&D
efforts, our ability to successfully identify, consummate and
integrate acquisitions, including the pending acquisition of Barr
Pharmaceuticals Inc., potential exposure to product liability claims
to the extent not covered by insurance, dependence on the
effectiveness of our patents and other protections for innovative
products, significant operations worldwide that may be adversely
affected by terrorism, political or economical instability or major
hostilities, supply interruptions or delays that could result from the
complex manufacturing of our products and our global supply chain,
environmental risks, fluctuations in currency, exchange and interest
rates, and other factors that are discussed in this report and in our
other filings with the U.S. Securities and Exchange Commission
(”SEC”).

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