Teva’s Generic Version of EpiPen® (Epinephrine Injection, USP) Auto-Injector 0.3 mg Now Available in Limited Quantity in the United States
PARSIPPANY, N.J.--(BUSINESS WIRE)--Nov 27, 2018--Teva Pharmaceutical Industries (NYSE and TASE: TEVA) today announced the release of limited doses of the FDA-approved generic version of EpiPen ®1 (epinephrine injection, USP) Auto-Injector, 0.3 mg, in the US. Teva’s generic version of the EpiPen Jr ® (epinephrine injection, USP) Auto-Injector, 0.15 mg, and an additional supply of Teva’s generic version of the EpiPen ® (epinephrine injection, USP) Auto-Injector, 0.3 mg is expected in 2019. The publically-available Wholesale Acquisition Cost (WAC) 2 for the product is $300.
Brendan O’Grady, EVP and Head of North America Commercial at Teva said, “We’re pleased to provide access to Epinephrine Injection (Auto-Injector) for patients who may experience life-threatening allergic emergencies and we’re fully dedicated toward ensuring additional supply in 2019.”
With over 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 US. Currently, one in seven generic prescriptions dispensed in the US is filled with a Teva generic product.
About EPINEPHRINE Injection
Epinephrine Injection (Auto-Injector) is a prescription medicine in a disposable, prefilled automatic injection device (auto-injector) used to treat life-threatening, allergic emergencies including anaphylaxis in people who are at risk for or have a history of serious allergic emergencies. Each device contains a single dose of epinephrine.
Epinephrine Injection (Auto-Injector) is for immediate self (or caregiver) administration and does not take the place of emergency medical care. You should get emergency help right away after using Epinephrine Injection (Auto-Injector).
IMPORTANT SAFETY INFORMATION
Anaphylaxis can be life-threatening, can happen within minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or unknown causes. Use Epinephrine Injection (Auto-Injector) right away when you have an allergic emergency (anaphylaxis). Get emergency medical help right away. You may need further medical attention. You may need to use a second Epinephrine Injection (Auto-Injector) if symptoms continue or recur. Only a healthcare provider should give additional doses of epinephrine if you need more than 2 injections for a single anaphylaxis episode.
Epinephrine Injection (Auto-Injector) should only be injected into the middle of your outer thigh (upper leg) through clothing if necessary. Do not inject the Epinephrine Injection (Auto-Injector) into your: veins, buttocks, fingers, toes, hands, or feet. If you inject a young child with Epinephrine Injection (Auto-Injector), hold their leg firmly in place before and during the injection to prevent injuries. If you accidentally inject Epinephrine Injection (Auto-Injector) into any other part of your body, go to the nearest emergency room right away. Tell the healthcare provider where on your body you received the accidental injection.
Rarely, patients who have used Epinephrine Injection (Auto-Injector) may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.
If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you use your Epinephrine Injection (Auto-Injector). Tell your healthcare provider about all known allergies, all your medical conditions and all the medicines you take, especially if you take asthma medicines.
Common side effects of Epinephrine Injection (Auto-Injector) include: fast, irregular or “pounding” heartbeat; sweating; headache; weakness; shakiness; paleness; feelings of over excitement, nervousness or anxiety; dizziness; nausea or vomiting; and breathing problems. These side effects may go away with rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Epinephrine Injection (Auto-Injector). For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
For more information, please see accompanying .
A copy may be requested from Teva US Medical Information at 888-4-TEVA-USA (888-838-2872) or firstname.lastname@example.org, or Teva’s Public Relations or Investor Relations contacts.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 45,000 professionals, committed to improving the lives of millions of patients. 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 Teva’s epinephrine injection USP, 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:
and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2017, including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at and . 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 EpiPen ® and EpiPen Jr ® are registered trademarks of Mylan ®.
2 Teva does not set the price that a pharmacy charges for a particular drug and does not has visibility or control into the price of the drug in the marketplace.
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PUB: 11/27/2018 10:06 AM/DISC: 11/27/2018 10:06 AM