Teva Announces Its Launch of the First Generic PERFOROMIST®, Formoterol Fumarate Inhalation Solution, 20 mcg/2 ML, Used to T...
23 June 2021 - 7:18AM
Business Wire
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced its U.S.
launch of the first generic version of twice daily PERFOROMIST®,
formoterol fumarate inhalation solution, 20 mcg/2 ML, indicated to
treat bronchoconstriction in patients with chronic obstructive
pulmonary disease (COPD), including chronic bronchitis and
emphysema.
“Teva is pleased to provide patients with first-to-market access
to a generic version of PERFOROMIST® (formoterol fumarate
inhalation solution),” said Christine Baeder, SVP, Chief Operating
Officer US Generics, Teva USA.
With over 500 generic medicines available, Teva has the largest
portfolio of FDA-approved generic products on the market and holds
the leading position in first-to-file opportunities, with more than
100 pending first-to-files in the U.S. Currently, 1 in 11 generic
prescriptions dispensed in the U.S. is filled with a Teva generic
product.
PERFOROMIST® (formoterol fumarate inhalation solution) has
annual sales of more than $299 million in the U.S., according to
IQVIA data as of March 2021.
About Formoterol Fumarate Inhalation Solution, 20
mcg/2 ML
- Formoterol fumarate inhalation solution is a long-acting beta2
adrenergic agonist (LABA) used to control the symptoms of COPD in
adults with COPD. COPD is a chronic lung disease that includes
chronic bronchitis, emphysema, or both.
- Formoterol fumarate inhalation solution is only for use with
a nebulizer.
- LABA medicines such as formoterol fumarate inhalation solution
help the muscles around the airways in your lungs stay relaxed to
prevent symptoms, such as wheezing, cough, chest tightness, and
shortness of breath.
- Formoterol fumarate inhalation solution is for long-term use
and should be taken 2 times each day, to improve the symptoms of
COPD for better breathing.
- Formoterol fumarate inhalation solution is not used to treat
sudden symptoms of COPD.
- Formoterol fumarate inhalation solution is not for the
treatment of asthma. It is not known if formoterol fumarate
inhalation solution is safe and effective in people with
asthma.
Formoterol fumarate inhalation solution should not be used in
children. It is not known if formoterol fumarate inhalation
solution is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not use formoterol fumarate inhalation solution if you
have asthma.
Before using formoterol fumarate inhalation solution tell
your healthcare provider about all of your medical conditions,
including if you:
- have heart problems
- have high blood pressure
- have diabetes
- have seizures
- have thyroid problems
- have liver problems
- are pregnant or plan to become pregnant. It is not known if the
medicine formoterol in formoterol fumarate inhalation solution
passes into breast milk and if it can harm your baby.
- are breastfeeding or plan to breastfeed. It is not known if the
medicine formoterol in formoterol fumarate inhalation solution
passes into breast milk and if it can harm your baby.
Tell your healthcare provider about all the medicines you
take including prescription and over-the-counter medicines,
vitamins and herbal supplements. Formoterol fumarate inhalation
solution and certain other medicines may interact with each other.
This may cause serious side effects.
What are the possible side effects of formoterol fumarate
inhalation solution?
Formoterol fumarate inhalation solution can cause serious
side effects, including:
- people with asthma who take long-acting LABA medicines, such
as formoterol fumarate inhalation solution, without also using a
medicine called an inhaled corticosteroid, have an increased risk
of serious problems from asthma, including being hospitalized,
needing a tube placed in their airway to help them breathe, or
death.
- Call your healthcare provider if breathing problems worsen
over time while using formoterol fumarate inhalation solution.
You may need a different treatment.
- Get emergency medical care if:
- breathing problems worsen quickly
- you use your rescue inhaler medicine, but it does not relieve
your breathing problems
- COPD symptoms that get worse over time. If your COPD
symptoms worsen over time, do not increase your dose of formoterol
fumarate inhalation solution, instead call your healthcare
provider.
- using too much of a LABA medicine may cause: chest pain,
fast and irregular heartbeat, tremor, increased blood pressure,
headache, or nervousness.
- sudden shortness of breath immediately after use of
formoterol fumarate inhalation solution. Sudden shortness of
breath may be life-threatening. If you have sudden breathing
problems immediately after inhaling your medicine, call your
healthcare provider or go to nearest hospital emergency room right
away.
- effects on your heart, including fast or irregular
heartbeat, chest pain or increased blood pressure.
- changes in laboratory levels, including high levels of
blood sugar (hyperglycemia) and low levels of potassium
(hypokalemia), which may cause symptoms of muscle spasm, muscle
weakness or abnormal heart rhythm.
- serious allergic reactions including rash, hives, swelling
of the face, mouth, and tongue, and breathing problems. Call
your healthcare provider or get emergency medical care if you get
any symptoms of a serious allergic reaction.
Common side effects of formoterol fumarate inhalation
solution include: headache, muscle cramps, dizziness, tremor,
nausea, tiredness, nervousness, vomiting, trouble sleeping, dry
mouth, or diarrhea.
Tell your healthcare provider if you get any side effect that
bothers you or that does not go away. These are not all the
possible side effects of formoterol fumarate inhalation solution.
For more information, ask your healthcare provider or pharmacist
for more information.
Call your doctor for medical advice about side effects. You are
encouraged to report side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information, please see accompanying full Prescribing
Information. A copy may be requested from Teva U.S. Medical
Information at 888-TEVA-USA (888-838 2872), druginfo@tevapharm.com,
or Teva’s Public Relations or Investor Relations contacts.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 3,500
products in nearly every therapeutic area. Around 200 million
people around the world take a Teva medicine every day, and are
served by one of the largest and most complex supply chains in the
pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. Learn more at www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding the launch of our generic version of PERFOROMIST®
(formoterol fumarate) Inhalation Solution, 20 mcg/2 ML in the
United States, which are based on management’s current beliefs and
expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements.
Important factors that could cause or contribute to such
differences include risks relating to:
- the commercial success of our generic version of PERFOROMIST®
(formoterol fumarate) Inhalation Solution, 20 mcg/2 ML;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; consolidation of our customer base and commercial
alliances among our customers; delays in launches of new generic
products; the increase in the number of competitors targeting
generic opportunities and seeking U.S. market exclusivity for
generic versions of significant products; our ability to develop
and commercialize biopharmaceutical products; competition for our
specialty products, including AUSTEDO®, AJOVY® and COPAXONE®; our
ability to achieve expected results from investments in our product
pipeline; our ability to develop and commercialize additional
pharmaceutical products; and the effectiveness of our patents and
other measures to protect our intellectual property rights;
- our substantial indebtedness, which may limit our ability to
incur additional indebtedness, engage in additional transactions or
make new investments, may result in a further downgrade of our
credit ratings; and our inability to raise debt or borrow funds in
amounts or on terms that are favorable to us;
- our business and operations in general, including: uncertainty
regarding the magnitude, duration, and geographic reach of the
COVID-19 pandemic and its impact on our business, financial
condition, operations, cash flows, and liquidity and on the economy
in general; our ability to successfully execute and maintain the
activities and efforts related to the measures we have taken or may
take in response to the COVID-19 pandemic and associated costs
therewith; effectiveness of our optimization efforts; our ability
to attract, hire and retain highly skilled personnel; manufacturing
or quality control problems; interruptions in our supply chain;
disruptions of information technology systems; breaches of our data
security; variations in intellectual property laws; challenges
associated with conducting business globally, including political
or economic instability, major hostilities or terrorism; costs and
delays resulting from the extensive pharmaceutical regulation to
which we are subject or delays in governmental processing time due
to travel and work restrictions caused by the COVID-19 pandemic;
the effects of reforms in healthcare regulation and reductions in
pharmaceutical pricing, reimbursement and coverage; significant
sales to a limited number of customers; our ability to successfully
bid for suitable acquisition targets or licensing opportunities, or
to consummate and integrate acquisitions; and our prospects and
opportunities for growth if we sell assets;
- compliance, regulatory and litigation matters, including:
failure to comply with complex legal and regulatory environments;
increased legal and regulatory action in connection with public
concern over the abuse of opioid medications and our ability to
reach a final resolution of the remaining opioid-related
litigation; scrutiny from competition and pricing authorities
around the world, including our ability to successfully defend
against the U.S. Department of Justice criminal charges of Sherman
Act violations; potential liability for patent infringement;
product liability claims; failure to comply with complex Medicare
and Medicaid reporting and payment obligations; compliance with
anti-corruption sanctions and trade control laws; and environmental
risks;
- other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
significant increases in tax liabilities; and 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;
and other factors discussed in this press release and in our
Annual Report on Form 10-K for the year ended December 31, 2020,
including in the sections captioned "Risk Factors” and “Forward
Looking Statements.” 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 contained herein, whether as a result of new
information, future events or otherwise. You are cautioned not to
put undue reliance on these forward-looking statements.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210622006088/en/
IR United States Kevin C. Mannix (215) 591-8912
Israel Yael Ashman 972 (3) 914-8262
PR United States Kelley Dougherty (973) 658-0237
Israel Yonatan Beker 972 (54) 888 5898
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Apr 2023 to Apr 2024