Teva Announces Launch of First-to-Market Generic Version of Narcan® (Naloxone Hydrochloride Nasal Spray), in the U.S.
23 December 2021 - 8:30AM
Business Wire
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical
Industries Ltd. (NYSE and TASE: TEVA), today announced the launch
of a first-to-market generic version of Narcan®1 (naloxone
hydrochloride nasal spray), in the United States.
Naloxone hydrochloride nasal spray is a prescription medicine
used for the treatment of an opioid emergency such as an overdose
or a possible opioid overdose with signs of breathing problems and
severe sleepiness or not being able to respond.
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 12 generic prescriptions dispensed in the U.S. is filled with a
Teva generic product.
What is naloxone hydrochloride nasal spray?
- Naloxone hydrochloride nasal spray is a prescription medicine
used for the treatment of an opioid emergency such as an overdose
or a possible opioid overdose with signs of breathing problems and
severe sleepiness or not being able to respond.
- Naloxone hydrochloride nasal spray is to be given right away
and does not take the place of emergency medical care. Get
emergency medical help right away after giving the first dose of
naloxone hydrochloride nasal spray, even if the person wakes
up.
- Naloxone hydrochloride nasal spray is safe and effective in
children for known or suspected opioid overdose.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
naloxone hydrochloride nasal spray? Naloxone hydrochloride
nasal spray is used to temporarily reverse the effects of opioid
medicines. The medicine in naloxone hydrochloride nasal spray has
no effect in people who are not taking opioid medicines. Always
carry naloxone hydrochloride nasal spray with you in case of an
opioid emergency.
- Use naloxone hydrochloride nasal spray right away if you or
your caregiver think signs or symptoms of an opioid emergency are
present, even if you are not sure, because an opioid emergency can
cause severe injury or death. Signs and symptoms of an opioid
emergency may include:
- unusual sleepiness and you are not able to awaken the person
with a loud voice or by rubbing firmly on the middle of their chest
(sternum)
- breathing problems including slow or shallow breathing in
someone difficult to awaken or who looks like they are not
breathing
- the black circle in the center of the colored part of the eye
(pupil) is very small, sometimes called “pinpoint pupils,” in
someone difficult to awaken
- Family members, caregivers, or other people who may have to use
naloxone hydrochloride nasal spray in an opioid emergency should
know where naloxone hydrochloride nasal spray is stored and how to
give naloxone hydrochloride before an opioid emergency
happens.
- Get emergency medical help right away after giving the first
dose of naloxone hydrochloride nasal spray. Rescue breathing or
CPR (cardiopulmonary resuscitation) may be given while waiting for
emergency medical help.
- The signs and symptoms of an opioid emergency can return after
naloxone hydrochloride nasal spray is given. If this happens, give
another dose after 2 to 3 minutes using a new naloxone
hydrochloride nasal spray and watch the person closely until
emergency help is received.
Who should not use naloxone hydrochloride nasal spray? Do not
use naloxone hydrochloride nasal spray if you are allergic to
naloxone hydrochloride or any of the ingredients in naloxone
hydrochloride nasal spray. See the end of the Patient Information
Leaflet found at the end of the Prescribing Information for a
complete list of ingredients in naloxone hydrochloride nasal
spray.
What should I tell my healthcare provider before using
naloxone hydrochloride nasal spray? Before using naloxone
hydrochloride nasal spray, tell your healthcare provider about all
of your medical conditions, including if you:
- have heart problems
- are pregnant or plan to become pregnant. Use of naloxone
hydrochloride nasal spray may cause withdrawal symptoms in your
unborn baby. Your unborn baby should be examined by a healthcare
provider right away after you use naloxone hydrochloride nasal
spray.
- are breastfeeding or plan to breastfeed. It is not known if
naloxone hydrochloride passes into your breast milk.
Tell your healthcare provider about the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
What are the possible side effects of naloxone hydrochloride
nasal spray? Naloxone hydrochloride nasal spray may cause serious
side effects, including:
- Sudden opioid withdrawal symptoms. In someone who has
been using opioids regularly, opioid withdrawal symptoms can happen
suddenly after receiving naloxone hydrochloride nasal spray and may
include: body aches, diarrhea, increased heart rate, fever, runny
nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting,
nervousness, restlessness or irritability, shivering or trembling,
stomach cramping, weakness, or increased blood pressure.
In infants under 4 weeks old who have been receiving opioids
regularly, sudden opioid withdrawal may be life-threatening if not
treated the right way. Signs and symptoms include: seizures, crying
more than usual, and increased reflexes.
These are not all of the possible side effects of naloxone
hydrochloride nasal spray. 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.
Please read the Patient Information Leaflet in the full
Prescribing Information.
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, 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. You
can identify these forward-looking statements by the use of words
such as “should,” “expect,” “anticipate,” “estimate,” “target,”
“may,” “project,” “guidance,” “intend,” “plan,” “believe” and other
words and terms of similar meaning and expression in connection
with any discussion of future operating or financial performance.
Important factors that could cause or contribute to such
differences include risks relating to the development, approval and
commercialization of our generic products; 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 additional
pharmaceutical products, and the effectiveness of our patents and
other measures to protect our intellectual property rights; our
substantial indebtedness; our business and operations in general,
including uncertainty regarding 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; 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; other financial and economic
risks; and other factors discussed in our Annual Report on Form
10-K for the year ended December 31, 2020, including in the section
captioned “Risk Factors.” 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 Narcan® is a registered trademark of Emergent Operations
Ireland Limited.
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