Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced its launch
of the first available 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg
strength generic version of Absorica®1 (isotretinoin) capsules for
the treatment of severe recalcitrant nodular acne in non-pregnant
patients 12 years of age and older with multiple inflammatory
nodules with a diameter of 5 mm or greater.
“Teva’s first-to-market generic version of Absorica®
(isotretinoin) capsules in the U.S. is an important treatment
option for patients living with severe recalcitrant nodular acne,
and who are unresponsive to conventional acne therapy, including
antibiotics,” said Christine Baeder, SVP, Chief Operating Officer
US Generics, Teva USA. “With more than 30 dermatological products
in Teva’s generics portfolio, we are proud to add another
accessible option for patients.”
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.
Isotretinoin oral capsules have annual sales of more than $158
million in the U.S., according to IQVIA data as of February
2021.
About Isotretinoin Oral Capsules
Isotretinoin capsules are prescription medicines used in
patients 12 years of age and older, who are not pregnant, for the
treatment of severe acne (nodular acne) that cannot be cleared up
by any other acne treatments, including antibiotics.
It is not known if isotretinoin capsules are safe and effective
in children less than 12 years of age.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
isotretinoin capsules?
- Isotretinoin capsules can harm your unborn baby, including
birth defects (deformed babies), loss of a baby before birth
(miscarriage), death of the baby, and early (premature) births.
Patients who are pregnant or who plan to become pregnant must not
take isotretinoin capsules. Patients must not get pregnant:
- for 1 month before starting isotretinoin capsules
- during treatment with isotretinoin capsules
- for 1 month after stopping isotretinoin capsules
If you get pregnant during treatment with isotretinoin
capsules, stop taking it right away and call your healthcare
provider. Healthcare providers and patients should report all
cases of pregnancy during treatment or 1 month after stopping
treatment to:
- FDA MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch,
and
- the iPLEDGE® Pregnancy Registry at 1-866-495-0654 or
www.ipledgeprogram.com
Because isotretinoin capsules can cause birth defects,
isotretinoin capsules are only for patients who can understand and
agree to carry out all of the instructions in the iPLEDGE
Program.
- Serious mental health problems, including:
- depression
- psychosis(seeing or hearing things that are not
real)
- suicide. Some patients taking isotretinoin capsules have
had thoughts about hurting themselves or putting an end to their
own lives (suicidal thoughts). Some people tried to end their own
lives. Some people have ended their own lives.
Stop taking isotretinoin capsules and call your healthcare
provider right away if you or a family member notices that you have
any of the following signs and symptoms of depression or
psychosis:
- start to feel sad or have crying spells
- lose interest in activities you once enjoyed
- sleep too much or have trouble sleeping
- become more irritable, angry, or aggressive than usual (for
example, temper outbursts, thoughts of violence)
- have a change in your appetite or body weight
- have trouble concentrating
- withdraw from your friends or family
- feel like you have no energy
- have feelings of worthlessness or guilt
- start having thoughts about hurting yourself or taking your own
life (suicidal thoughts)
- start acting on dangerous impulses
- start seeing or hearing things that are not real
Your healthcare provider may tell you to see a mental healthcare
professional if you had any of these symptoms.
Do not take isotretinoin capsules if you:
- are pregnant, plan to become pregnant, or become pregnant
during isotretinoin capsules treatment. Isotretinoin capsules
cause severe birth defects. See “What is the most important
information I should know about isotretinoin capsules?”
- are allergic to isotretinoin, vitamin A, or any of the
ingredients in isotretinoin capsules. See the end of the
Medication Guide in the full Prescribing Information for a complete
list of ingredients in isotretinoin capsules.
Before taking isotretinoin capsules, tell your healthcare
provider if you or a family member has any of the following health
conditions:
- mental health problems
- asthma
- liver problems
- diabetes
- heart disease
- increase blood fat levels (cholesterol and triglycerides)
- bone loss (osteoporosis), weak bones or any other bone
problems
- an eating problem called anorexia nervosa (where people eat too
little)
- food or medicine allergies, including aspirin or
tartrazine
Tell your healthcare provider if you are pregnant or
breastfeeding. Do not breastfeed during treatment or for at
least 8 days after the last dose of isotretinoin capsules.
Tell your healthcare provider about all of the medicines you
take including prescription and over-the-counter medicines,
vitamins and herbal supplements, including St. John’s wort.
Isotretinoin capsules and certain other medicines can affect each
other, sometimes causing serious side effects.
Do not take the following medicines during treatment with
isotretinoin capsules:
- vitamin A supplements
- tetracycline antibiotics
Know the medicines you take. Keep a list of them to show to your
healthcare provider and pharmacist. Do not take any new medicine
without talking with your healthcare provider.
What should I avoid while taking isotretinoin
capsules?
- Do not give blood during treatment with isotretinoin
capsules and for one month after stopping isotretinoin capsules. If
someone who is pregnant gets your donated blood, their baby may be
exposed to isotretinoin and may be born with birth defects.
- Do not take other medicines or herbal products with
isotretinoin capsules unless you talk to your healthcare provider.
See “Before taking isotretinoin capsules”
- Do not drive at night until you know if isotretinoin
capsules have affected your vision. Isotretinoin capsules may
decrease your ability to see in the dark.
- Do not have cosmetic procedures to smooth your skin,
including waxing, dermabrasion, or laser procedures, during
treatment with isotretinoin capsules and for at least 6 months
after you stop. Isotretinoin capsules can increase your chance
of scarring from these procedures. Check with your healthcare
provider for advice about when you can have cosmetic
procedures.
- Avoid sunlight and ultraviolet lights as much as
possible. Tanning machines use ultraviolet lights. Isotretinoin
capsules may make your skin more sensitive to light.
- Do not share isotretinoin capsules with other people.
Isotretinoin capsules can cause birth defects and other serious
health problems.
What are the possible side effects of isotretinoin
capsules?
Isotretinoin capsules can cause serious side effects,
including:
- See “What is the most important information I should know
about isotretinoin capsules?”
- increased pressure in the brain (intracranial
hypertension). Isotretinoin capsules can increase the pressure
in your brain. This can lead to permanent loss of eyesight, and in
rare cases, death. Stop taking isotretinoin capsules and call your
healthcare provider right away if you get any of these signs of
increased brain pressure: bad headache, blurred vision, dizziness,
nausea or vomiting, seizures (convulsions), or stroke.
- serious skin problems. Skin rash can occur in patients
taking isotretinoin capsules. Sometimes rash can be serious and may
lead to death. Stop using isotretinoin capsules and call your
healthcare provider right away if you get: conjunctivitis (red or
inflamed eyes, like “pink eye”); rash with a fever; blisters on
legs, arms or face; sores in your mouth, throat, nose or eyes; or
peeling of your skin.
- inflammation of your pancreas (pancreatitis) can happen
in patients who take isotretinoin capsules and can lead to death.
Call your healthcare provider right away if you have any of the
following symptoms of pancreatitis: severe upper stomach (abdomen)
pain, swelling of your stomach, nausea and vomiting, or fever.
- increased blood fat (lipid) levels. Isotretinoin
capsules can raise blood fat levels (cholesterol and
triglycerides). Your healthcare provider will do blood tests to
check your lipids before and during treatment. These problems
usually go away when isotretinoin capsules treatment is
finished.
- hearing problems. Stop using isotretinoin capsules and
call your healthcare provider if your hearing gets worse or if you
have ringing in your ears. Your hearing loss may be permanent.
- liver problems, including hepatitis. Your healthcare
provider will do tests to check your liver before and during
treatment with isotretinoin capsules. Call your healthcare provider
if you get: yellowing of your skin or the whites of your eyes, pain
on the right side of your stomach area (abdomen), dark urine,
bleeding or bruising more easily than normal.
- inflammation of your digestive tract (inflammatory bowel
disease).Stop taking isotretinoin capsules and call your
healthcare provider if you get: severe stomach, chest or bowel
pain; nausea or vomiting; trouble swallowing or painful swallowing;
new or worsening heartburn; diarrhea; or rectal bleeding.
- bone and muscle problems. Bone problems include bone
pain, softening or thinning (which may lead to fractures). Tell
your healthcare provider if you plan hard physical activity during
treatment with isotretinoin capsules. Tell your healthcare provider
if you get: back pain, joint pain or muscle pain, or a broken bone.
Tell all healthcare providers that you take isotretinoin capsules
if you break a bone. Stop isotretinoin capsules and call your
healthcare provider right away if you have muscle weakness. Muscle
weakness with or without pain can be a sign of serious muscle
damage. Isotretinoin capsules may stop long bone growth in
teenagers who are still growing.
- vision problems. Stop taking isotretinoin capsules and
call your healthcare provider right away if you have any vision
changes. Isotretinoin capsules may affect your ability to see in
the dark. This usually goes away after you stop taking isotretinoin
capsules, but it may be permanent. Some patients get dry eyes
during treatment. If you wear contact lenses, you may have trouble
wearing them during and after you stop treatment with isotretinoin
capsules.
- serious allergic reactions. Stop taking isotretinoin
capsules and get emergency medical help right away if you get
hives, a swollen face or mouth, or have trouble breathing. Stop
taking isotretinoin capsules and call your healthcare provider if
you get a fever, rash, or red patches or bruises on your legs.
- blood sugar problems, including diabetes. Tell your
healthcare provider if you are very thirsty or urinate more than
usual.
The most common side effects of isotretinoin capsules
include:
- dry lips
- dry skin
- back pain
- dry eyes
- joint pain
- nose bleeds
- headache
- upper respiratory tract infection (common cold)
- chapped lips or swelling of the lips
- skin reactions
- muscle problems
- eye problems, including decreased vision
These are not all of the possible side effects of isotretinoin
capsules. 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 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and
40 mg strength generic Isotretinoin oral capsules 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 10 mg, 20 mg, 25 mg, 30 mg, 35 mg
and 40 mg strength generic Isotretinoin oral capsules;
- 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.
1 Absorica® is a registered trademark of Sun Pharmaceutical
Industries Inc.
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IR Contacts United States Kevin C. Mannix (215)
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PR Contacts United States Kelley Dougherty (973)
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