Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced the launch
of its 250 mg and 500 mg strength generic Erythromycin tablets—a
therapeutic equivalent for the reference listed drug (RLD)
Erythromycin Tablets from Arbor Pharmaceuticals. Teva generic
Erythromycin tablets are indicated to treat a variety of bacterial
infections, and to prevent initial or recurrent attacks of
rheumatic fever in patients allergic to penicillin.
With nearly 550 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
approximately 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.
Erythromycin oral tablets has annual sales of more than $49
million in the U.S., according to IQVIA data as of January
2021.
About Erythromycin Tablets
Erythromycin tablets are a prescription antibiotic medication
used in the treatment of infections caused by specific, susceptible
strains of microorganisms in the following diseases: respiratory
tract infections; listeriosis; skin and skin structure infections;
pertussis (whooping cough); diphtheria; erythrasma; intestinal
amebiasis; acute pelvic inflammatory disease; conjunctivitis in
newborns; pneumonia of infancy; urogenital infections during
pregnancy; uncomplicated urethral, endocervical, or rectal
infections in adults in specific situations; nongonococcal
urethritis in specific situations; primary syphilis; and
Legionnaires’ Disease.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
erythromycin tablets?
Erythromycin tablets should not be used if you have a known
hypersensitivity to this antibiotic or if you are taking
terfenadine, astemizole, cisapride, pimozide, ergotamine, or
dihydroergotamine. If you are unsure, ask your doctor if you are
taking any of these medications.
Erythromycin tablets should not be taken together with certain
statins including lovastatin or simvastatin. Talk to your doctor if
you are currently taking statins to help control your
cholesterol.
Erythromycin tablets can cause liver problems including
increased liver enzymes; and certain types of hepatitis, with or
without jaundice.
Erythromycin tablets can cause problems with your heart and
heart rate resulting in death. Erythromycin tablets should be
avoided in patients with heart or heart rate problems, and/or are
taking medications to treat these conditions. Elderly patients may
have a higher risk of drug-associated effects on the heart and
heart rate. Tell your doctor about all medications you take
including prescription and over-the-counter medicines, vitamins and
herbal supplements.
Erythromycin tablets should not be used to prevent syphilis in
infants born to women treated during pregnancy with oral
erythromycin.
Erythromycin tablets may cause a condition called Clostridium
difficile associated diarrhea (CDAD). The condition can range in
severity from mild diarrhea to fatal inflammation of the colon.
Erythromycin tablets should only be used to treat bacterial
infections. They do not treat viral infections (e.g., the common
cold). Although it is common to feel better early in the course of
taking erythromycin tablets, the medication should be taken exactly
as directed. Skipping doses or not completing the full course of
therapy may (1) decrease the effectiveness of the immediate
treatment and (2) increase the likelihood that bacteria will
develop resistance and will not be treatable by erythromycin
tablets or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually
ends when the antibiotic is discontinued. Sometimes after starting
treatment with antibiotics, patients can develop watery and bloody
stools (with or without stomach cramps and fever) even as late as
two or more months after having taken the last dose of the
antibiotic. If this occurs, contact your doctor as soon as
possible.
What should I tell my doctor before taking erythromycin
tablets?
Tell your doctor about all medications you take including
prescription and over-the-counter medicines, vitamins and herbal
supplements. Serious side effects can occur when taking
erythromycin tablets with other medications.
What are the possible side effects of erythromycin
tablets?
The most frequent side effects of erythromycin tablets are
nausea, vomiting, abdominal pain, diarrhea and anorexia. Symptoms
of hepatitis, liver dysfunction and/or abnormal liver function test
results may occur.
Inflammation of the colon (colitis) may occur during or after
antibacterial treatment.
Erythromycin tablets have been associated with heart problems
and heart rate problems which can be fatal.
Allergic reactions ranging from a rash to severe
life-threatening allergic reactions have occurred. Skin reactions
ranging from mild to severe have been reported rarely.
There have been reports of kidney disorder with erythromycin
tablets.
There have been rare reports of inflammation of the pancreas and
convulsions.
There have been isolated reports of reversible hearing loss
occurring chiefly in patients with poor kidney function and in
patients receiving high doses of erythromycin.
These are not all the possible side effects of erythromycin
tablets.
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 250 mg and 500 mg strength generic
Erythromycin tablets 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 250 mg and 500 mg strength
generic Erythromycin tablets;
- 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.
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IR Contacts United States Kevin C. Mannix (215) 591-8912
Israel Yael Ashman 972 (3) 914-8262 PR Contacts
United States Kelley Dougherty (973) 658-0237 Israel
Yonatan Beker 972 (54) 888 5898
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