share_log

Teva Announces Launch of an Authorized Generic of Flector®Patch(diclofenac epolamine topical patch) in the United States

Teva Announces Launch of an Authorized Generic of Flector®Patch(diclofenac epolamine topical patch) in the United States

Teva 宣佈在美國推出 Flector® 貼片(雙氯芬酸依泊胺外用貼片)的授權通用
Business Wire ·  2019/03/01 21:08

Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the launch of an authorized generic of Flector®1Patch, 1.3 %, in the U.S.

Teva製藥工業有限公司(紐約證券交易所和多倫多證券交易所市場代碼:TEVA)今天宣佈,在美國推出FLECTOR®1貼片的授權仿製藥。

Diclofenac Epolamine Topical Patch, 1.3%, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the topical treatment of acute pain due to minor strains, sprains and contusions.

雙氯芬酸依波拉明外用貼片,1.3%,是一種非類固醇抗炎藥(NSAID),用於局部治療因輕微拉傷、扭傷和挫傷而引起的急性疼痛。

“The launch of our authorized generic of Flector®Patch in the U.S. is an important addition to Teva’s portfolio of over 40 generic pain management medicines,” said Brendan O’Grady, EVP and Head of North America Commercial.

Teva執行副總裁兼北美商業部負責人布倫丹·奧格雷迪説:“我們授權的仿製藥Flector®貼片在美國的推出是對Teva的40多種非專利止痛藥物組合的重要補充。

With nearly 500 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 U.S. Currently, one in eight generic prescriptions dispensed in the U.S. is filled with a Teva generic product. With the launch of Diclofenac Epolamine Topical Patch, 1.3%, Teva now has over 16 medicines in the Analgesics and Antipyretics, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) therapeutic area in the U.S.

Teva擁有近500種仿製藥,是市場上FDA批准的仿製藥產品組合最多的公司,在首次申請機會方面處於領先地位,在美國有100多種待申請的仿製藥。目前,美國配發的仿製藥中,每八種就有一種是Teva仿製藥。隨着雙氯芬酸依波拉明局部貼片的推出,1.3%,Teva現在在美國的止痛藥和解熱藥,非類固醇抗炎藥(NSAIDs)治療領域擁有16種以上的藥物。

Flector®Patch had annual sales of $123 million in the U.S., according to IQVIA data as of December 2018.

根據IQVIA截至2018年12月的數據,Flector®補丁在美國的年銷售額為1.23億美元。

About Diclofenac Epolamine Topical Patch, 1.3%

關於雙氯芬酸依波拉明局部貼片,1.3%

Diclofenac Epolamine Topical Patch, 1.3% is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.

雙氯芬酸依波拉明外用貼片,1.3%,用於局部治療因輕微拉傷、扭傷和挫傷引起的急性疼痛。

IMPORTANT SAFETY INFORMATION

重要安全信息

WARNING: NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.Diclofenac Epolamine Topical Patch, 1.3% is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

警告:非甾體抗炎藥會增加嚴重心血管血栓事件的風險,包括心肌梗死和中風,這可能是致命的。這種風險可能發生在治療的早期,並可能隨着使用時間的延長而增加。1.3%雙氯芬酸依波拉明貼劑在冠狀動脈旁路移植術中的禁忌症.非甾體抗炎藥導致嚴重胃腸道(GI)不良事件的風險增加,包括出血、潰瘍和胃腸穿孔,這些可能是致命的。這些事件可以在使用過程中的任何時間發生,並且沒有警告症狀。老年患者和既往有消化性潰瘍疾病和/或胃腸道出血史的患者發生嚴重胃腸道事件的風險更大。

Diclofenac Epolamine Topical Patch, 1.3% is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product. Diclofenac Epolamine Topical Patch, 1.3% is contraindicated in patients with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients. Diclofenac Epolamine Topical Patch, 1.3% is contraindicated for use on non-intact or damaged skin resulting from any etiology, including, exudative dermatitis, eczema, infected lesions, burns, or wounds.

1.3%雙氯芬酸依波拉明局部貼片,禁忌用於對雙氯芬酸或藥物產品的任何成分有已知過敏反應(例如過敏反應和嚴重皮膚反應)的患者。雙氯芬酸依波拉明局部貼片,1.3%,禁忌用於服用阿司匹林或其他非類固醇抗炎藥後有哮喘、蕁麻疹或其他過敏性反應病史的患者。據報道,這類患者對非類固醇抗炎藥的過敏反應嚴重,有時甚至是致命的。1.3%雙氯芬酸依波拉明局部貼片,禁止用於因任何原因引起的不完整或受損的皮膚,包括滲出性皮炎、濕疹、感染性皮損、燒傷或傷口。

The following serious adverse reactions are also associated with the use of NSAIDs, including diclofenac: hepatotoxicity; new onset or worsening of hypertension; heart failure; fluid retention; edema; renal toxicity; hyperkalemia; anaphylactic reactions; exacerbation of aspirin-sensitive asthma; serious skin reactions, such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN); premature closure of fetal ductus arteriosus; anemia; and increased risk of bleeding events. Concomitant use of oral and topical NSAIDs may result in a higher rate of hemorrhage, and more frequent abnormal creatinine, urea and hemoglobin.

以下嚴重不良反應也與使用非類固醇抗炎藥有關,包括雙氯芬酸:肝毒性;新的高血壓發病或惡化;心力衰竭;液體滯留;水腫;腎毒性;高鉀血癥;過敏反應;阿司匹林敏感型哮喘加重;嚴重皮膚反應,如剝脱性皮炎、史蒂文斯-約翰遜綜合徵(SJS)和中毒性表皮壞死鬆解(TEN);胎兒動脈導管過早關閉;貧血;以及出血事件風險增加。同時使用口服和外用非甾體抗炎藥可能會導致更高的出血率,以及更頻繁的異常肌酐、尿素和血紅蛋白。

In controlled clinical trials, the most common adverse reactions for Diclofenac Epolamine Topical Patch, 1.3% and placebo patch were application site reactions, occurring in 11% and 12% of patients, respectively. Gastrointestinal disorders were reported for Diclofenac Epolamine Topical Patch, 1.3% and placebo patch in 9% and 6% of patients, respectively.

在對照臨牀試驗中,雙氯芬酸依波拉明貼片和安慰劑貼片最常見的不良反應分別為11%和12%,分別為1.3%和12%。雙氯芬酸依波拉明外用貼片和安慰劑貼片分別有9%和6%的患者報告了胃腸功能障礙,分別為1.3%和6%。

For more information, please see accompanying Full Prescribing Information , including the Boxed Warning. A copy may be requested from Teva US Medical Information at 888-TEVA-USA (888-838-2872), druginfo@tevapharm.com , or Teva’s Public Relations or Investor Relations contacts.

有關更多信息,請參閲隨附的完整説明信息,包括方框警告。可致電888-Teva-USA(888-838-2872)向Teva美國醫療信息索取一份副本,或發送電子郵件至DrugInfo@teVAMIAN.com,或聯繫Teva的公共關係或投資者關係。

About Teva

關於Teva

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 .

Teva製藥工業有限公司(紐約證券交易所和多倫多證券交易所市場代碼:Teva)是仿製藥領域的全球領先企業,在特定領域擁有創新的治療方法,包括中樞神經系統、疼痛和呼吸。我們在幾乎每個治療領域提供高質量的仿製藥和藥物,以滿足未得到滿足的患者需求。我們在仿製藥、專業藥、非處方藥和原料藥領域建立了堅實的基礎,建立在一個多世紀的傳統基礎上,擁有完全集成的研發職能、強大的運營基礎以及全球基礎設施和規模。我們努力以對社會和環境負責的方式行事。我們總部設在以色列,在全球擁有生產和研究設施,僱傭了4.5萬名專業人員,致力於改善數百萬患者的生活。欲瞭解更多信息,請訪問網站:www.tevamar.com。

Cautionary Note Regarding Forward-Looking Statements

有關前瞻性陳述的注意事項

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the launch and potential benefits of the authorized generic of Flector® Patch, 1.3 %, 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:commercial success of the authorized generic version of Flector®Patch;our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; the uncertainty of commercial success of AJOVY®or AUSTEDO®; competition from companies with greater resources and capabilities; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations; consolidation of our customer base and commercial alliances among our customers; 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 products, both from competing products and increased regulation; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; our ability to take advantage of high-value opportunities; the difficulty and expense of obtaining licenses to proprietary technologies; 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: failure to effectively execute our restructuring plan announced in December 2017; uncertainties related to, and failure to achieve, the potential benefits and success of our new senior management team and organizational structure; harm to our pipeline of future products due to the ongoing review of our R&D programs; our ability to develop and commercialize additional pharmaceutical products; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; compliance with sanctions and other trade control laws; 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; variations in intellectual property laws that may adversely affect our ability to manufacture our products; challenges associated with conducting business globally, including adverse effects of political or economic instability, major hostilities or terrorism; significant sales to a limited number of customers in our U.S. market; 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: 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; governmental investigations into selling and marketing practices; potential liability for patent infringement; 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; 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;

本新聞稿包含符合1995年《私人證券訴訟改革法》的前瞻性陳述,涉及FLECTOR®補丁授權仿製藥1.3%的推出和潛在好處。這些前瞻性陳述是基於管理層目前的信念和預期,受大量已知和未知的風險和不確定性的影響,這些風險和不確定性可能會導致我們未來的結果、業績或成就與此類前瞻性陳述明示或暗示的結果、業績或成就大不相同。可能導致或促成這種差異的重要因素包括與以下風險有關的風險:FLECTOR®貼片授權仿製藥的商業成功;我們在市場上成功競爭的能力,包括:我們在很大程度上依賴我們的仿製藥;對我們特殊產品的競爭,特別是對我們的領先藥物Copaxone®的競爭,它面臨着來自現有的和潛在的額外仿製藥和口服替代品的競爭;AJOVY®或AUSTEDO®商業成功的不確定性;來自擁有更多資源和能力的公司的競爭;製藥公司努力限制仿製藥的使用,包括通過立法和法規;鞏固我們的客户基礎和客户之間的商業聯盟;瞄準仿製藥機會併為重要產品的仿製藥尋求美國市場排他性的競爭對手數量增加;與我們的產品相關的價格侵蝕, 競爭產品和加強的監管;新產品發佈的延遲和我們從產品線投資中實現預期結果的能力;我們利用高價值機會的能力;獲得專有技術許可證的困難和費用;以及我們專利和其他保護我們知識產權的措施的有效性;我們的鉅額債務可能限制我們產生額外債務、進行額外交易或進行新投資的能力,可能導致我們的信用評級進一步下調;以及我們無法以對我們有利的金額或條款舉債或借款;我們的業務和運營總體上包括:未能有效執行我們於2017年12月宣佈的重組計劃;與我們新的高級管理團隊和組織結構的潛在好處和成功相關的不確定性,以及未能實現這些不確定因素;由於正在對我們的研發計劃進行審查,對我們未來產品的流水線造成損害;我們開發更多藥品並將其商業化的能力;我們與美國政府就我們的《反海外腐敗法》調查達成一致後,可能會產生額外的不利後果;遵守制裁和其他貿易管制法律;製造或質量控制問題,這些問題可能損害我們高質量生產的聲譽,需要代價高昂的補救措施;我們的供應鏈中斷;我們的或第三方信息技術系統中斷或我們的數據安全遭到破壞;未能招聘或保留關鍵人員;知識產權法的變化可能對我們的產品製造能力產生不利影響;與在全球開展業務相關的挑戰,包括政治或經濟不穩定的不利影響, 重大敵對行動或恐怖主義;在美國市場向有限數量的客户大量銷售;我們成功競標合適的收購目標或許可機會,或完成和整合收購的能力;以及如果我們出售資產,我們的增長前景和機會;合規、監管和訴訟事項,包括:我們受到廣泛的政府監管導致的成本和延誤;醫療保健監管改革的影響以及藥品定價、報銷和覆蓋範圍的減少;政府對銷售和營銷行為的調查;專利侵權的潛在責任;產品責任索賠;政府對我們的專利和解協議加強審查;未能遵守複雜的Medicare和Medicaid報告和支付義務;以及環境風險;其他金融和經濟風險,包括:我們受到貨幣波動和限制以及信用風險的影響;我們無形資產的潛在減值;納税義務可能大幅增加;以及政府計劃或税收優惠的終止或到期,或我們業務的變化對我們整體有效税率的影響;

and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2018, including the sections thereof 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.

以及我們在截至2018年12月31日的10-K表格年度報告中討論的其他因素,包括其中標題為“風險因素”的部分。前瞻性陳述僅在發出之日起發表,我們不承擔任何義務更新或修改本文中包含的任何前瞻性陳述或其他信息,無論是新信息的結果。

1Flector®is a registered trademark of IBSA Institute Biochimique SA, licensed by Alpharma Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

1Flector®是IBSA Institute BioChimique SA的註冊商標,由輝瑞的子公司AlPharma PharmPharmticals LLC授權。

2019 Business Wire, Inc., All rights reserved.

2019 Business Wire,Inc.,版權所有。

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
    搶先評論