Zenara制药获得美国FDA批准，其盐酸舍曲林胶囊首个仿制药上市，并享有180天的CGT独占期-动脉网

Zenara Pharma Receives U.S. FDA Approval for First Generic of Sertraline Hydrochloride Capsules with 180-Day CGT Exclusivity

CISION 等信源发布 2025-08-01 08:58

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HYDERABAD, India

印度海得拉巴

，

July 31, 2025

2025年7月31日

/PRNewswire/ --

Zenara Pharma Private Limited

禅药私营有限公司

('Zenara'), a

('Zenara')，一个

Biophore

生物载体

company, today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for

公司今日宣布，已收到美国食品药品监督管理局 (FDA) 对其简略新药申请 (ANDA) 的最终批准。

Sertraline Hydrochloride Capsules, 150 mg and 200 mg

盐酸舍曲林胶囊，150毫克和200毫克

. This approval marks the first FDA-approved generic equivalent of the reference listed drug marketed by Almatica Pharma, LLC.

. 此次批准标志着首个由Almatica Pharma, LLC公司销售的参比制剂的FDA批准仿制药等效物。

The product has also been granted

该产品还被授予了

Competitive Generic Therapy (CGT)

竞争性仿制药疗法 (CGT)

designation by the FDA. As the first approved applicant under this pathway, Zenara's ANDA has secured

FDA的指定。作为该途径下的首个获批申请人，Zenara的ANDA已确保了

180 days of marketing exclusivity

180天的市场独占期

in the U.S., which commenced with the product's launch

在美国，产品上市时就开始了

。

Sertraline Hydrochloride Capsules

盐酸舍曲林胶囊

are classified as selective serotonin reuptake inhibitors (SSRIs) and are indicated for the treatment of

被归类为选择性5-羟色胺再摄取抑制剂（SSRIs），适用于治疗

Major Depressive Disorder (MDD)

重度抑郁症 (MDD)

in adults and

在成人中和

Obsessive-Compulsive Disorder (OCD)

强迫症 (OCD)

in adults and pediatric patients aged six years and older.

在六岁及以上的成人和儿科患者中。

Commenting on the milestone,

评论这一里程碑，

Dr.

博士

Srinivas Arutla

斯里尼瓦斯·阿鲁特拉

, CEO of

，首席执行官

Zenara Pharma Pvt. Ltd.,

泽纳拉制药私人有限公司，

said:

说：

'Receiving the first generic approval for Sertraline Hydrochloride Capsules highlights

“盐酸舍曲林胶囊获得首个通用名药物批准，突显了

Zenara's strong R&D capabilities and operational excellence. We remain committed to our mission of delivering to patients, early access to high-quality, affordable pharmaceuticals.'

泽纳拉强大的研发能力和卓越的运营能力。我们始终致力于我们的使命，为患者提供早日获得高质量、可负担的药品的机会。

According to IQVIA™ sales data for the 12-month period ending

根据IQVIA™截至以下12个月期间的销售数据

June 2025

2025年6月

, U.S. sales of the reference product totaled approximately

美国参考产品的销售总额约为

$35.5 million

3550万美元

。

About Zenara:

关于Zenara:

Zenara Pharma Private Limited – a

Biophore

生物载体

company, is a vertically integrated pharmaceutical company, committed to delivering high-quality pharmaceuticals that are safe, effective, and affordable to patients. Zenara is an industry leader in Research and Development and Manufacturing of Affordable and Quality finished dosage pharmaceutical Products.

公司是一家垂直整合的制药公司，致力于为患者提供安全、有效且价格合理的高质量药品。Zenara 是研发和制造经济实惠、质量优良的成品剂量制药产品的行业领导者。

Zenara is focused on the therapeutic areas of Neurology, Orphan Drugs, Complex Products, Women's health, Cardiology, Imaging, and Contrast Agents among others. For more information, please visit us on the .

Zenara专注于神经病学、孤儿药、复杂产品、女性健康、心脏病学、影像学和造影剂等治疗领域。欲了解更多信息，请访问我们的网站。

web

网页

, or connect with us on our

，或者在我们的平台上联系我们

领英

page.

页面。

*All brand names and trademarks are the property of their respective owners

*所有品牌名称和商标均为其各自所有者的财产

U.S. FDA,

美国食品药品监督管理局，