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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宣布获得美FDA对多剂量盐酸美沙酮注射剂的最终批准
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.

新泽西州伯克利高地,2024年12月18日 /PRNewswire/ -- 布雷肯里奇药品有限公司,作为东和国际在美国的子公司,负责市场营销、分销和销售美国的仿制药,今天宣布美国食品和药物管理局已最终批准其盐酸美沙酮注射液USP,200 mg/20 mL (10 mg/mL) 多剂量瓶,并计划立即推出。

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.

盐酸美沙酮注射液USP,200 mg/20 mL (10 mg/mL) 多剂量瓶适用于(I)管理需要长时间治疗并依赖每日阿片类镇痛药的严重和持续性疼痛,而其他治疗方案不充分;(II)用于暂时治疗无法口服药物的阿片类依赖患者。

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

将我们的产品范围扩展到机构渠道,扩大了我们对关键医疗需求的影响。

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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.

此次新产品上市反映了公司短期和中期的策略,旨在扩大在机构渠道的市场份额,并增强其产品组合。通过向美国市场推出一系列肿瘤学、自身免疫、罕见疾病和支持性护理产品,布雷肯里奇展示了其对创新和增长的承诺。这些重大进展与东和国际的整体健康愿景完美契合——涵盖身心和情感的健康,呼应世界卫生组织对健康的全面定义。

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".

布雷肯里奇药品有限公司总裁兼首席商务官布赖恩·盖伊表示:"通过将产品范围扩展到机构渠道,我们增强了在行业内精准有效地广泛满足关键医疗需求的能力。这一战略决策还彰显了我们满足医疗专业人员不断变化需求的承诺,为患者治疗带来了新的维度,以提供更优质的整体护理"。

About Breckenridge Pharmaceutical, Inc.

关于布雷肯里奇药品有限公司

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.

布雷肯里奇药品有限公司(新泽西州),东和国际(西班牙巴塞罗那)的美国子公司,与国内外的制造商合作,为美国患者提供优质、具有成本效益的仿制药。我们致力于客户服务、按时交付、可靠供应和优质制造,努力影响我们和客户服务的患者的健康。

For further information, please contact:

如需更多信息,请联系:

Towa International / Breckenridge Pharmaceutical, Inc.

Towa International / Breckenridge 药品公司

Rosa Horri, External Comm and IR

Rosa Horri, 外部通讯与投资者关系

Email: [email protected]

电子邮件: [email protected]

SOURCE Breckenridge Pharmaceutical, Inc.

来源:Breckenridge 药品公司

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