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Breckenridge Announces Final FDA Approval for Methadone Hydrochloride Multi-Dose Injection

Breckenridge Announces Final FDA Approval for Methadone Hydrochloride Multi-Dose Injection

Breckenridge宣佈獲得美FDA對多劑量鹽酸美沙酮注射劑的最終批准
PR Newswire ·  12/19 00:30

BERKELEY HEIGHTS, N.J., Dec. 18, 2024 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc., the U.S. subsidiary of Towa International that markets, distributes, and sells generic pharmaceuticals in the United States, announced today that the U.S. Food and Drug Administration has granted final approval of its Methadone Hydrochloride Injection USP, 200 mg/20 mL (10 mg/mL) Multi-Dose Vial which it plans to launch immediately.

新澤西州伯克利高地,2024年12月18日 /PRNewswire/ -- 佈雷肯裏奇藥品有限公司,作爲東和國際在美國的子公司,負責市場營銷、分銷和銷售美國的仿製藥,今天宣佈美國食品和藥物管理局已最終批准其鹽酸美沙酮注射液USP,200 mg/20 mL (10 mg/mL) 多劑量瓶,並計劃立即推出。

Methadone Hydrochloride Injection USP, 200 mg/20 mL (10 mg/mL) Multi-Dose Vial is indicated (I) for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate, and (II) for use in temporary treatment of opioid dependence in patients unable to take oral medication.

鹽酸美沙酮注射液USP,200 mg/20 mL (10 mg/mL) 多劑量瓶適用於(I)管理需要長時間治療並依賴每日阿片類鎮痛藥的嚴重和持續性疼痛,而其他治療方案不充分;(II)用於暫時治療無法口服藥物的阿片類依賴患者。

Expanding our product range into the institutional channel broadens our impact on critical healthcare needs

將我們的產品範圍擴展到機構渠道,擴大了我們對關鍵醫療需求的影響。

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This new launch reflects the company's short and medium-term strategy, aimed at expanding its presence in the institutional channel and enhancing its portfolio. By introducing a range of Oncology, Autoimmune, Rare Disease and Supportive Care products to the U.S. market, Breckenridge demonstrates its commitment to innovation and growth. These significant strides align seamlessly with Towa International's vision of holistic health—encompassing physical, mental, and emotional well-being—echoing the World Health Organization's comprehensive definition of health.

此次新產品上市反映了公司短期和中期的策略,旨在擴大在機構渠道的市場份額,並增強其產品組合。通過向美國市場推出一系列腫瘤學、自身免疫、罕見疾病和支持性護理產品,佈雷肯裏奇展示了其對創新和增長的承諾。這些重大進展與東和國際的整體健康願景完美契合——涵蓋身心和情感的健康,呼應世界衛生組織對健康的全面定義。

Brian Guy, President and CCO of Breckenridge Pharmaceutical, states, "By expanding the product range into the institutional channel, we enhance our ability to broadly address critical healthcare needs across the industry with precision and efficacy. This strategic decision also underscores our dedication to meeting the evolving demands of healthcare professionals, bringing a new dimension to patient treatment for better overall care".

佈雷肯裏奇藥品有限公司總裁兼首席商務官布賴恩·蓋伊表示:"通過將產品範圍擴展到機構渠道,我們增強了在行業內精準有效地廣泛滿足關鍵醫療需求的能力。這一戰略決策還彰顯了我們滿足醫療專業人員不斷變化需求的承諾,爲患者治療帶來了新的維度,以提供更優質的整體護理"。

About Breckenridge Pharmaceutical, Inc.

關於佈雷肯裏奇藥品有限公司

Breckenridge Pharmaceutical, Inc., (New Jersey), the U.S. subsidiary of Towa International (Barcelona, Spain), partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients. With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we strive to impact the health of the patients we and our customers serve.

佈雷肯裏奇藥品有限公司(新澤西州),東和國際(西班牙巴塞羅那)的美國子公司,與國內外的製造商合作,爲美國患者提供優質、具有成本效益的仿製藥。我們致力於客戶服務、按時交付、可靠供應和優質製造,努力影響我們和客戶服務的患者的健康。

For further information, please contact:

如需更多信息,請聯繫:

Towa International / Breckenridge Pharmaceutical, Inc.

Towa International / Breckenridge 藥品公司

Rosa Horri, External Comm and IR

Rosa Horri, 外部通訊與投資者關係

Email: [email protected]

電子郵件: [email protected]

SOURCE Breckenridge Pharmaceutical, Inc.

來源:Breckenridge 藥品公司

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