הגרסה הגנרית של טבע עבור EpiPen Jr® (זריקת אפינפרין), מזרק אוטומטי 0.15 מ"ג, זמינה עכשיו בארה"ב

ירושלים ופרסיפני, ניו ג'רזי, 20 באוגוסט, 2019 – טבע תעשיות פרמצבטיות בע"מ הודיעה היום על הזמינות של הגרסה הגנרית המאושרת FDA עבור ®EpiPen Jr (זריקת אפינפרין), מזרק אוטומטי 0.15 מ"ג, בארה"ב. המוצר זמין ברוב בתי המרקחת והמחיר-Wholesale Acquisition Cost  - עבור המוצר יהיה 300 דולר עבור אריזה של שניים.

"אנו שמחים להציע גישה לזריקת אפינפרין (מזרק אוטומטי) בשני חוזקים עבור מטופלים העלולים לחוות מקרי חירום מסכני חיים כתוצאה מהתקפות אלרגיות", אמר ברנדן או'גריידי, סמנכ"ל בכיר, מנהל החטיבה המסחרית בצפון אמריקה. "נמשיך לעבוד כדי להבטיח זמינות של שני החוזקים בארה"ב ואנו מתכוונים להאיץ את הייצור כדי לעמוד בצורך הדחוף לתרופה זו."

עם קרוב ל-500 תרופות גנריות זמינות, לטבע יש את פורטפוליו המוצרים הגנריים מאושרי FDA הגדול בשוק ומובילה בהזדמנויות השקה בבלעדיות (first to file), עם יותר מ-100 תיקי first to file תלויים ועומדים בארה"ב. כיום, 1 מכל 9 מרשמים גנריים הניתנים בארה"ב הוא למוצר של טבע.

הגרסה הגנרית של ®EpiPen ו- ®EpiPen Jr משתמשת במכשיר של ®Antares Pharma (NASDAQ: ATRS) VIBEX. לטבע ול- Antares יש הסכם בלעדי לרישיון, פיתוח ואספקה של מוצרי מזרק אפינפרין אוטומטי אשר טבע משווקת בארה"ב.

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).

Epinephrine Injection, 0.3 mg (Auto-Injector) is for patients who weigh 66 pounds or more (30 kilograms or more).  Epinephrine Injection, 0.15 mg (Auto-Injector) is for patients who weigh about 33 to 66 pounds (15 to 30 kilograms).  It is not known if Epinephrine Injection (Auto-Injector) is safe and effective in children who weigh less than 33 pounds (15 kilograms).

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 Full Prescribing Information.

A copy may be requested from Teva US Medical Information at 888-TEVA-USA (888-838-2872) or druginfo@tevapharm.com, or Teva’s Public Relations or Investor Relations contacts.

אודות טבע

טבע תעשיות פרמצבטיות בע"מ (NYSE & TASE: TEVA) מפתחת ומייצרת תרופות לשיפור חייהם של אנשים מזה למעלה ממאה שנה. אנו מובילים גלובליים בגנריקה ובתרופות ייחודיות, עם פורטפוליו הכולל יותר מ- 3,500 מוצרים בכמעט כל תחום טיפולי. בכל יום, כ-200 מיליון אנשים ברחבי העולם נוטלים תרופה של טבע, הודות לאחת ממערכות התפעול הגדולות והמורכבות בתעשייה הפרמצבטית. נוסף על מעמדנו המבוסס בגנריקה, יש לנו פעילות מחקר חדשני משמעותית התומכת בפורטפוליו המוצרים הייחודיים והביופרמצבטיים הגדל שלנו. למידע נוסף על החברה, בקרו באתר www.Teva.co.il

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. Important factors that could cause or contribute to such differences include risks relating to:

  • uncertainties relating to the potential benefits and success of our new structure and recent senior management changes as well as the potential success and our ability to effectively execute a restructuring plan;
  • our generics medicines business, including: that we are substantially more dependent on this business, with its significant attendant risks, following our acquisition of Allergan plc’s worldwide generic pharmaceuticals business (“Actavis Generics”); our ability to realize the anticipated benefits of the acquisition (and any delay in realizing those benefits) or difficulties in integrating Actavis Generics; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; price erosion relating to our generic products, both from competing products and as a result of increased governmental pricing pressures; and our ability to take advantage of high-value biosimilar opportunities;
  • our specialty medicines business, including: competition for our specialty products, especially Copaxone®, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; our ability to achieve expected results from investments in our product pipeline; competition from companies with greater resources and capabilities; and the effectiveness of our patents and other measures to protect our intellectual property rights;
  • our substantially increased indebtedness and significantly decreased cash on hand, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, and may result in a downgrade of our credit ratings;
  • our business and operations in general, including: our ability to develop and commercialize additional pharmaceutical products; manufacturing or quality control problems, which may damage our reputation for quality production and require costly remediation; interruptions in our supply chain; disruptions of our or third party information technology systems or breaches of our data security; the failure to recruit or retain key personnel;the restructuring of our manufacturing network, including potential related labor unrest; the impact of continuing consolidation of our distributors and customers; variations in patent laws that may adversely affect our ability to manufacture our products; our ability to consummate dispositions on terms acceptable to us; adverse effects of political or economic instability, major hostilities or terrorism on our significant worldwide operations; and our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions;
  • compliance, regulatory and litigation matters, including: costs and delays resulting from the extensive governmental regulation to which we are subject; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; governmental investigations into sales and marketing practices; potential liability for sales of generic products prior to a final resolution of outstanding patent litigation; 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; the significant increase in our intangible assets, which may result in additional substantial impairment charges; potentially 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 our Annual Report on Form 20-F for the year ended December 31, 2016 (“Annual Report”), including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. 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. 

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