Teva Announces Launch of First-to-Market Generic Version of Narcan® (Naloxone Hydrochloride Nasal Spray), in the U.S.
TEL AVIV, Israel & PARSIPPANY, N.J.--(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.
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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Source: Teva Pharmaceutical Industries Limited