仿制药提供商Sun Pharma下一代BLU-U®蓝光光动力治疗照明器获FDA批准，治疗光化性角化病-动脉网

Sun Pharma Announces FDA Approval of Next Generation BLU-U® Blue Light Photodynamic Therapy Illuminator for Actinic Keratosis

CISION 等信源发布 2025-05-16 20:58

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The BLU-U Model 4170E offers a compact, easy-to-use option with the same BLU-U safety and efficacy healthcare professionals have trusted for years.

BLU-U Model 4170E 提供了一种紧凑、易于使用的选项，具有多年来医疗专业人员信赖的相同 BLU-U 安全性和有效性。

MUMBAI, India

印度孟买

，

PRINCETON, N.J.

普林斯顿，新泽西州

and

和

BILLERICA, Mass.

马萨诸塞州比勒里卡

，

May 16, 2025

2025年5月16日

/PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) (together with its subsidiaries and/or associates referred as 'Sun Pharma') today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval application (PMA) approval of the next generation of BLU-U.

/PRNewswire/ -- Sun Pharmaceutical Industries Limited（路透社：SUN.BO，彭博社：SUNP IN，NSE：SUNPHARMA，BSE：524715）（连同其子公司和/或关联公司统称为“Sun Pharma”）今天宣布，美国食品和药物管理局 (FDA) 已批准下一代BLU-U的上市前批准申请 (PMA)。

Blue Light Photodynamic Therapy (PDT) Illuminator which features light emitting diode light (LED) panels as a replacement for the previous model's fluorescent tubes. The new model (LED BLU-U) in combination with LEVULAN

蓝光光动力疗法（PDT）照明器，采用发光二极管（LED）面板替代之前型号的荧光灯管。新型号（LED BLU-U）与LEVULAN结合使用。

KERASTICK

克腊斯蒂ック

(aminolevulinic acid HCl) Topical Solution, 20%, is indicated for the treatment of minimally to moderately thick actinic keratoses (AK) of the face, scalp, or upper extremities.

盐酸氨基乙酰丙酸（aminolevulinic acid HCl）20%外用溶液适用于治疗面部、头皮或上肢的轻度至中度厚的光化性角化病（AK）。

The new LED BLU-U is approved for the same indications as the previous model but takes up less space in a dermatologist's office, and has a more flexible five-panel shape, improved LED arrangement, lighter weight, and other updated functions that may increase patient comfort and ease of use.

新型LED BLU-U获批的适应症与前代型号相同，但占用皮肤科医生办公室的空间更小，具有更灵活的五面板形状、改进的LED布局、更轻的重量以及其他更新的功能，这些可能提高患者的舒适度和使用的便捷性。

'We are pleased to receive the FDA's approval of LED BLU-U and look forward to seeing the positive impact this next generation device will have for those living with actinic keratosis,' said

“我们很高兴收到FDA对LED BLU-U的批准，并期待看到这款下一代设备对日光性角化病患者产生的积极影响，”

Abhay Gandhi

阿布哈伊·甘地

, Sun Pharma North America CEO. 'As a company committed to innovation, we are confident that this new LED BLU-U model will provide improved efficiency and reliability while maintaining the safety and efficacy that healthcare professionals and people with AKs have come to trust from Sun Pharma.'

北美太阳制药公司首席执行官表示：“作为一家致力于创新的公司，我们相信这款新的LED BLU-U型号将提供更高的效率和可靠性，同时保持医疗专业人员和AK患者所信赖的太阳制药的安全性和有效性。”

The approval of LED BLU-U was granted under FDA's Real-Time Review Program, reflecting the robustness of the submission and Sun Pharma's continued collaboration with the Agency.

LED BLU-U 的批准是在 FDA 的实时审查计划下授予的，反映了提交材料的可靠性以及太阳制药与 FDA 的持续合作。

The LED BLU-U will be available for delivery in the near future. For details regarding availability, ordering, or implementation, please direct inquiries to your Sun Pharma Specialty Dermatology representative. For more information, healthcare professionals are encouraged to visit

LED BLU-U 将在不久的将来可供交付。有关可用性、订购或实施的详细信息，请向您的 Sun Pharma Specialty Dermatology 代表咨询。欲了解更多信息，鼓励医疗保健专业人员访问

www.levulanhcp.com

。

About Actinic Keratosis (AK)

关于光化性角化病 (AK)

AK is a chronic condition that can lead to skin cancer. AKs are rough, dry, and scaly patches on the skin resulting from extended sun exposure. These spots can vary in size from a tiny pinhead to a quarter and are commonly found on sun-exposed areas such as the face, scalp, arms and hands.

光化性角化病（AK）是一种可能导致皮肤癌的慢性疾病。光化性角化病表现为皮肤上粗糙、干燥和鳞片状的斑块，是长期暴露在阳光下的结果。这些斑点的大小可以从针头大小到25美分硬币大小不等，通常出现在面部、头皮、手臂和手等暴露在阳光下的区域。

About LEVULAN KERASTICK + BLU-U

关于LEVULAN KERASTICK + BLU-U

LEVULAN KERASTICK + BLU-U blue light is the only FDA-approved photodynamic therapy (PDT) that effectively targets and clears actinic keratosis (AK) on the face, scalp, arms and hands. LEVULAN KERASTICK (a topical 20% ALA [aminolevulinic acid] solution) + BLU-U blue light photodynamic therapy (PDT) has earned the trust of dermatologists for more than 20 years, offering a proven safe and effective treatment that can eliminate actinic keratoses (AKs) in one or two in-office visits..

LEVULAN KERASTICK + BLU-U蓝光是唯一获得FDA批准的光动力疗法（PDT），可有效针对并清除面部、头皮、手臂和手部的日光性角化病（AK）。LEVULAN KERASTICK（一种20% ALA [氨基乙酰丙酸] 外用溶液）+ BLU-U蓝光光动力疗法（PDT）在超过20年的时间里赢得了皮肤科医生的信任，提供了一种经过验证的安全有效的治疗方案，可以在一到两次门诊治疗中消除日光性角化病（AKs）。

About Sun Pharmaceutical Industries Limited. (CIN - L24230GJ1993PLC019050)

关于太阳制药工业有限公司。（公司识别号：L24230GJ1993PLC019050）

Sun Pharma is the world's leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in

太阳制药是全球领先的专业仿制药公司，在专业药物、仿制药和消费者保健产品领域均有涉足。它是最大的制药公司之一。

India

印度

and is a leading generic company in the U.S. as well as global emerging markets. Sun Pharma's high-growth global specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries.

并且是美国以及全球新兴市场领先的仿制药公司。太阳制药高增长的全球专科产品组合涵盖皮肤病学、眼科学和肿瘤皮肤病学的创新产品，占公司销售额的18%以上。公司垂直整合的业务为超过100个国家的医生和消费者提供值得信赖的高质量药物。

Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multicultural workforce drawn from over 50 nations. For further information, please visit .

其生产设施遍布六大洲。太阳制药为拥有来自 50 多个国家/地区的多元化员工队伍而感到自豪。欲了解更多信息，请访问。

www.sunpharma.com

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(Formerly Twitter).

（前身为Twitter）。

Disclaimer

免责声明

Statements in this 'Document' describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be 'forward looking statements' within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied.

本“文件”中描述公司目标、预测、估计、预期、计划或预测或行业状况或事件的声明，可能是适用证券法律法规和规定所指的“前瞻性声明”。实际结果、业绩或成就可能与这些明示或暗示的内容存在重大差异。

The Company undertakes no obligation to update or revise forward looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof..

公司不承担更新或修改前瞻性声明的义务，以反映此后出现的发展或情况，或反映在此日期之后发生的意外发展/情况。

Contacts: Sun Pharma

联系人：太阳制药（Sun Pharma）

Investors:

投资者：

Dr. Abhishek Sharma

阿比谢克·夏尔马博士

Tel + 91 22 4324 4324, Ext 2929

电话 +91 22 4324 4324，分机 2929

Tel Direct + 91 22 43242929

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