Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva
Pharmaceutical Industries Ltd.(NYSE and TASE: TEVA), today
announced the availability of a generic version of NuvaRing®1
(etonogestrel and ethinyl estradiol vaginal ring), 0.120 mg/0.015
mg per day, in the U.S. Teva’s AB-rated and bioequivalent
etonogestrel and ethinyl estradiol vaginal ring, is an
estrogen/progestin combination hormonal contraceptive (CHC)
indicated for use by women to prevent pregnancy.
“The launch of a generic version of NuvaRing Vaginal Ring in the
U.S. is an important addition to Teva’s generic portfolio,” said
Christine Baeder, SVP, Chief Operating Officer US Generics, Teva
USA. “With more than 40 generic products in our existing woman’s
health portfolio, we are proud to add another accessible
contraception option.”
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
over 100 pending first-to-files in the U.S. Currently, one in ten
generic prescriptions dispensed in the U.S. is filled with a Teva
generic product.
Etonogestrel and ethinyl estradiol vaginal ring products have
annual sales of more than $837 million in the U.S., according to
IQVIA data as of November 2020.
About Etonogestrel and Ethinyl Estradiol Vaginal Ring
Etonogestrel and ethinyl estradiol vaginal ring is indicated for
use by females of reproductive age to prevent pregnancy.
Etonogestrel and ethinyl estradiol is a flexible birth control
vaginal ring inserted in the vagina. The ring is to remain in place
for 3 weeks (21 days). It is removed for one week (7 days) and a
new vaginal ring is inserted on the same day of the week it was
inserted in the previous cycle.
Etonogestrel and ethinyl estradiol vaginal ring contains a
combination of a progestin and estrogen, 2 kinds of female
hormones. Birth control methods that contain both an estrogen and a
progestin are called combination hormonal contraceptives
(CHCs).
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
etonogestrel and ethinyl estradiol vaginal ring?
Do not use etonogestrel and ethinyl estradiol vaginal ring if
you smoke cigarettes and are over 35 years old. Smoking increases
your risk of serious cardiovascular side effects (heart and blood
vessel problems) from combination hormonal contraceptives (CHCs),
including death from heart attack, blood clots or stroke. This risk
increases with age and the number of cigarettes you smoke.
Hormonal birth control methods help to lower the chances of
becoming pregnant. They do not protect against HIV infection (AIDS)
and other sexually transmitted infections.
How well does etonogestrel and ethinyl estradiol vaginal ring
work?
Your chance of getting pregnant depends on how well you follow
the directions for using etonogestrel and ethinyl estradiol vaginal
ring. The better you follow the directions, the less chance you
have of getting pregnant.
Based on the results of a US clinical study, approximately 1 to
3 women out of 100 women may get pregnant during the first year
they use etonogestrel and ethinyl estradiol vaginal ring.
Who should not use etonogestrel and ethinyl estradiol vaginal
ring?
Do not use etonogestrel and ethinyl estradiol vaginal ring if
you:
- smoke and are over 35 years old
- have or have had blood clots in your arms, legs, eyes, or
lungs
- have an inherited problem with your blood that makes it clot
more than normal
- have had a stroke
- have had a heart attack
- have certain heart valve problems or heart rhythm problems that
can cause blood clots to form in the heart
- have high blood pressure that medicine can't control
- have diabetes with kidney, eye, nerve, or blood vessel
damage
- have certain kinds of severe migraine headaches with aura,
numbness, weakness, or changes in vision, or have any migraine
headaches if you are over age 35
- have liver disease, including liver tumors
- take any Hepatitis C drug combination containing
ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This
may increase levels of the liver enzyme “alanine aminotransferase”
(ALT) in the blood
- have unexplained vaginal bleeding
- are pregnant or think you may be pregnant. Etonogestrel and
ethinyl estradiol vaginal ring is not for pregnant women
- have or have had breast cancer or any cancer that is sensitive
to female hormones
- are allergic to etonogestrel, ethinyl estradiol or any of the
ingredients in etonogestrel and ethinyl estradiol vaginal ring. See
the list of ingredients in etonogestrel and ethinyl estradiol
vaginal ring at the end of this leaflet
Hormonal birth control methods may not be a good choice for you
if you have ever had jaundice (yellowing of the skin or eyes)
caused by pregnancy or related to previous use of hormonal birth
control.
Tell your healthcare provider if you have ever had any of the
conditions listed above. Your healthcare provider can suggest
another method of birth control.
What should I tell my healthcare provider before using
etonogestrel and ethinyl estradiol vaginal ring?
Before you use etonogestrel and ethinyl estradiol vaginal
ring tell your healthcare provider if you:
- have any medical conditions
- smoke
- are pregnant or think you are pregnant
- recently had a baby
- recently had a miscarriage or abortion
- have a family history of breast cancer
- have or have had breast nodules, fibrocystic disease, an
abnormal breast x-ray, or abnormal mammogram
- use tampons and have a history of toxic shock syndrome
- have been diagnosed with depression
- have had liver problems including jaundice during
pregnancy
- have or have had elevated cholesterol or triglycerides
- have or have had gallbladder, liver, heart, or kidney
disease
- have diabetes
- have a history of jaundice (yellowing of the skin or eyes)
caused by pregnancy (also called cholestasis of pregnancy)
- have a history of scanty or irregular menstrual periods
- have any condition that makes the vagina become irritated
easily
- have or have had high blood pressure
- have or have had migraines or other headaches or seizures
- are scheduled for surgery. Etonogestrel and ethinyl estradiol
vaginal ring may increase your risk of blood clots after surgery.
You should stop using etonogestrel and ethinyl estradiol vaginal
ring at least 4 weeks before you have surgery and not restart it
until at least 2 weeks after your surgery
- are scheduled for any laboratory tests. Certain blood tests may
be affected by hormonal birth control methods
- are breastfeeding or plan to breastfeed. Hormonal birth control
methods that contain estrogen, like etonogestrel and ethinyl
estradiol vaginal ring, may decrease the amount of milk you make. A
small amount of hormones from etonogestrel and ethinyl estradiol
vaginal ring may pass into your breast milk. Consider another
non-hormonal method of birth control until you are ready to stop
breastfeeding
- have (or have ever had) an allergic reaction while using
etonogestrel and ethinyl estradiol vaginal ring, including hives,
swelling of the face, lips, tongue, and/or throat causing
difficulty in breathing or swallowing (anaphylaxis and/or
angioedema)
Tell your healthcare provider about all medicines and herbal
products you take, including prescription and over-the-counter
medicines, vitamins and herbal supplements.
Some medicines and herbal products may make hormonal birth
control less effective, including, but not limited to:
- certain anti-seizure medicines (such as barbiturates,
carbamazepine, felbamate, oxcarbazepine, phenytoin, rufinamide and
topiramate)
- medicine to treat fungal infections (griseofulvin)
- certain combinations of HIV medicines, (such as nelfinavir,
ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir,
lopinavir/ritonavir, and tipranavir/ritonavir)
- certain hepatitis C (HCV) medicines (such as boceprevir and
telaprevir)
- non-nucleoside reverse transcriptase inhibitors (such as
efavirenz and nevirapine)
- medicine to treat tuberculosis (such as rifampicin and
rifabutin)
- medicine to treat high blood pressure in the vessels of the
lung (bosentan)
- medicine to treat chemotherapy-induced nausea and vomiting
(aprepitant)
- St John’s wort
Use an additional barrier contraceptive method (such as a male
condom with spermicide) when you take medicines that may make
etonogestrel and ethinyl estradiol vaginal ring less effective.
Since the effect of another medicine on etonogestrel and ethinyl
estradiol vaginal ring may last up to 28 days after stopping the
medicine, it is necessary to use the additional barrier
contraceptive method for that long to help prevent you from
becoming pregnant. While using etonogestrel and ethinyl estradiol
vaginal ring, you should not use certain female barrier
contraceptive methods such as a vaginal diaphragm, cervical cap or
female condom as your back-up method of birth control because
etonogestrel and ethinyl estradiol vaginal ring may interfere with
the correct placement and position of a diaphragm, cervical cap or
female condom.
Some medicines and grapefruit juice may increase the level of
ethinyl estradiol in your blood if used together, including:
- the pain reliever acetaminophen
- ascorbic acid (vitamin C)
- medicines that affect how your liver breaks down other
medicines (such as itraconazole, ketoconazole, voriconazole,
fluconazole, clarithromycin, erythromycin, and diltiazem)
- certain HIV medicines (atazanavir/ritonavir and indinavir)
- non-nucleoside reverse transcriptase inhibitors (such as
etravirine)
- medicines to lower cholesterol such as atorvastatin and
rosuvastatin
Hormonal birth control methods may interact with lamotrigine, a
medicine used for seizures. This may increase the risk of seizures,
so your healthcare provider may need to adjust your dose of
lamotrigine.
Women on thyroid replacement therapy may need increased doses of
thyroid hormone.
Ask your healthcare provider if you are not sure if you take any
of the medicines listed above. Know the medicines you take. Keep a
list of them to show your doctor and pharmacist when you get a new
medicine.
What are the possible side effects of using etonogestrel and
ethinyl estradiol vaginal ring?
See “What is the most important information I should know
about etonogestrel and ethinyl estradiol vaginal ring?”
Etonogestrel and ethinyl estradiol vaginal ring may cause
serious side effects, including:
blood clots. Like pregnancy, combination hormonal birth
control methods increase the risk of serious blood clots (see
following graph), especially in women who have other risk factors,
such as smoking, obesity, or age greater than 35. This increased
risk is highest when you first start using a combination hormonal
birth control method or when you restart the same or different
combination hormonal birth control method after not using it for a
month or more. Talk with your healthcare provider about your risk
of getting a blood clot before using etonogestrel and ethinyl
estradiol vaginal ring or before deciding which type of birth
control is right for you.
In some studies of women who used etonogestrel and ethinyl
estradiol vaginal ring, the risk of getting a blood clot was
similar to the risk in women who used combination birth control
pills.
Other studies have reported that the risk of blood clots was
higher for women who use combination birth control pills containing
desogestrel (a progestin similar to the progestin in etonogestrel
and ethinyl estradiol vaginal ring) than for women who use
combination birth control pills that do not contain
desogestrel.
It is possible to die or be permanently disabled from a
problem caused by a blood clot, such as heart attack or stroke.
Some examples of serious blood clots are blood clots in the:
- legs (deep vein thrombosis)
- lungs (pulmonary embolus)
- eyes (loss of eyesight)
- heart (heart attack)
- brain (stroke)
Call your healthcare provider right away if you have:
- leg pain that does not go away
- sudden shortness of breath
- sudden blindness, partial or complete
- severe pain or pressure in your chest
- sudden, severe headache unlike your usual headaches
- weakness or numbness in an arm or leg, or trouble speaking
- yellowing of the skin or eyeballs
Other serious risks include:
- Toxic Shock Syndrome (TSS). Some of the symptoms are much the
same as the flu, but they can become serious very quickly. Call
your healthcare provider or get emergency treatment right away if
you have the following symptoms:
- sudden high fever
- vomiting
- diarrhea
- fainting or feeling faint when standing up
- a sunburn-like rash
- muscle aches
- dizziness
- allergic reaction, including hives, swelling of the face, lips,
tongue, and/or throat causing difficulty in breathing or swallowing
(anaphylaxis and/or angioedema)
- liver problems, including liver tumors
- high blood pressure
- gallbladder problems
- accidental insertion into bladder
- symptoms of a problem called angioedema if you already have a
family history of angioedema
The most common side effects of etonogestrel and ethinyl
estradiol vaginal ring are:
- tissue irritation inside your vagina or on your cervix
- headache (including migraine)
- mood changes (including depression, especially if you had
depression in the past). Call your healthcare provider immediately
if you have any thoughts of harming yourself.
- etonogestrel and ethinyl estradiol vaginal ring problems,
including the ring slipping out or causing discomfort
- nausea and vomiting
- vaginal discharge
- weight gain
- vaginal discomfort
- breast pain, discomfort, or tenderness
- painful menstrual periods
- abdominal pain
- acne
- less sexual desire
Some women have spotting or light bleeding during etonogestrel
and ethinyl estradiol vaginal ring use. If these symptoms occur, do
not stop using etonogestrel and ethinyl estradiol vaginal ring. The
problem will usually go away. If it doesn’t go away, check with
your healthcare provider.
Other side effects seen with etonogestrel and ethinyl estradiol
vaginal ring include breast discharge; vaginal injury (including
pain, discomfort, and bleeding) associated with broken rings; and
penis discomfort of the partner (such as irritation, rash,
itching).
Less common side effects seen with combination hormonal birth
control include:
- Blotchy darkening of your skin, especially on your face
- High blood sugar, especially in women who already have
diabetes
- High fat (cholesterol, triglycerides) levels in the blood
There have been reports of the ring becoming stuck to the
vaginal tissue and having to be removed by a healthcare provider.
Call your healthcare provider if you are unable to remove your
etonogestrel and ethinyl estradiol vaginal ring.
Tell your healthcare provider about any side effect that bothers
you or that does not go away. These are not all the possible side
effects of etonogestrel and ethinyl estradiol vaginal ring. For
more information, ask your healthcare provider or pharmacist. Call
your healthcare provider for medical advice about side effects.
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 read the Patient Information Leaflet in the
accompanying full Prescribing Information and Boxed
Warning.
For more information, please see accompanying full Prescribing
Information, including the Boxed Warning. 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 NuvaRing®
(etonogestrel and ethinyl estradiol) vaginal ring 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 NuvaRing®
(etonogestrel and ethinyl estradiol) vaginal ring;
- 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; the increase in the number of
competitors targeting generic opportunities and seeking U.S. market
exclusivity for generic versions of significant products;
competition for our specialty products, especially COPAXONE®, our
leading medicine, which faces competition from existing and
potential additional generic versions, competing glatiramer acetate
products and orally-administered alternatives; the uncertainty of
commercial success of AJOVY® or AUSTEDO®; competition from
companies with greater resources and capabilities; delays in
launches of new products and our ability to achieve expected
results from investments in our product pipeline; ability to
develop and commercialize biopharmaceutical products; efforts of
pharmaceutical companies to limit the use of generics, including
through legislation and regulations 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 restructuring plan announced in
December 2017; our ability to attract, hire and retain highly
skilled personnel; our ability to develop and commercialize
additional pharmaceutical products; compliance with anti-corruption
sanctions and trade control laws; manufacturing or quality control
problems; interruptions in our supply chain, including due to
potential effects of the COVID-19 pandemic on our operations and
business in geographic locations impacted by the pandemic and on
the business operations of our suppliers; disruptions of
information technology systems; breaches of our data security;
variations in intellectual property laws; challenges associated
with conducting business globally, including adverse effects of the
COVID-19 pandemic, political or economic instability, major
hostilities or terrorism; 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; our prospects and opportunities for growth if we sell
assets; and potential difficulties related to the operation of our
new global enterprise resource planning (ERP) system;
- compliance, regulatory and litigation matters, including: our
ability to successfully defend against the U.S. Department of
Justice criminal charges of Sherman Act violations; increased legal
and regulatory action in connection with public concern over the
abuse of opioid medications in the U.S. and our ability to reach a
final resolution of the remaining opioid-related litigation; costs
and delays resulting from the extensive governmental regulation to
which we are subject or delays in governmental processing time due
to modified government operations due to the COVID-19 pandemic,
including effects on product and patent approvals due to the
COVID-19 pandemic; the effects of reforms in healthcare regulation
and reductions in pharmaceutical pricing, reimbursement and
coverage; governmental investigations into S&M practices;
potential liability for patent infringement; product liability
claims; increased government scrutiny of our patent settlement
agreements; failure to comply with complex Medicare and Medicaid
reporting and payment obligations; 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, in our
Quarterly Reports on Form 10-Q for the first, second and third
quarters of 2020 and in our Annual Report on Form 10-K for the year
ended December 31, 2019, 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.
1 NuvaRingis a registered trademark of Merck Sharp & Dohme
B.V., a subsidiary of Merck & Co., Inc.
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