The company received final approval from the USFDA for its New Drug Application (NDA) for ZITUVIO™ (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg

该公司获得了USFDA对ZITUVIO新药申请（NDA）的最终批准™（西他列汀）片剂，25毫克，50毫克和100毫克

AHMEDABAD, India, Oct. 20, 2023 /PRNewswire/ -- Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as 'Zydus') today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for ZITUVIO™ (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg..

2023年10月20日，印度艾哈迈达巴德/PRNewswire/-Zydus Lifesciences Limited（包括其子公司/附属公司，以下简称“Zydus”）今天宣布，美国食品和药物管理局（FDA）批准其新药申请（NDA）为ZITUVIO™（西他列汀）片剂，25mg，50mg和100mg。。

ZITUVIO™ contains active ingredient Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

ZITUVIO™含有活性成分西他列汀，一种二肽基肽酶-4（DPP-4）抑制剂，作为饮食和运动的辅助手段，用于改善2型糖尿病成人的血糖控制。

The approval of ZITUVIO™ is based on research, development, regulatory and manufacturing work performed by Zydus teams. ZITUVIO™ has undergone quality testing for Nitrosamines and potential genotoxic impurities as per current USFDA standards. ZITUVIO™ is compliant with current USFDA standards of Nitrosamines in Sitagliptin containing products..

ZITUVIO的批准™基于Zydus团队进行的研究，开发，监管和制造工作。ZITUVIO™已根据现行USFDA标准对亚硝胺和潜在的遗传毒性杂质进行了质量测试。ZITUVIO™符合目前USFDA关于含西他列汀产品中亚硝胺的标准。。

'The ZITUVIO™ approval builds on Zydus' long-term commitment to offer healthcare professionals a new affordable treatment option in connection with diabetes management,' said Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited.

'ZITUVIO™Zydus Lifesciences Limited总经理Sharvil Patel博士说，批准建立在Zydus长期承诺的基础上，为医疗保健专业人员提供与糖尿病管理相关的新的负担得起的治疗方案。

'We are pleased to be able to receive such a milestone approval for Zydus. Through our industry leading capabilities, we pride ourselves in finding innovative ways to bring value to the healthcare systems by providing affordable medicines for our patients. We look forward to bringing additional innovative products in the future that align with our purpose to empower patients to live healthier and more fulfilled lives,' said Dr.

“我们很高兴能够获得Zydus的这样一个里程碑式的批准。通过我们的行业领先能力，我们为自己的患者提供负担得起的药物，为寻找创新的方法为医疗保健系统带来价值而感到自豪。博士说，我们期待在未来带来更多创新产品，这些产品符合我们的目标，即使患者能够过上更健康，更充实的生活。

Punit Patel, CEO of Zydus Pharmaceuticals, Americas..

美洲Zydus制药公司首席执行官Punit Patel。。

According to IQVIA™ (MAT Aug-2023), U.S. market for DPP-IV inhibitors and its combinations is US$ 10 bn.

根据IQVIA™（MAT Aug-2023），DPP-IV抑制剂及其组合的美国市场为100亿美元。

About Zydus

关于Zydus

The Zydus Group with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs 25000 people worldwide and is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that impact lives.

Zydus集团的首要目标是赋予人们自由生活更健康和更充实的生活的能力，是一家创新的全球生命科学公司，旨在发现，开发，制造和销售广泛的医疗保健疗法。该集团在全球拥有25000人，其使命是通过影响生活的优质医疗保健解决方案为生命科学开辟新的可能性。

The group aspires to transform lives through pathbreaking discoveries. For more details visit www.zyduslife.com..

该集团渴望通过开创性的发现改变生活。欲了解更多详情，请访问www.zyduslife.com。。

IMPORTANT SAFETY INFORMATION FOR ZITUVIO™ (Sitagliptin)

ZITUVIO的重要安全信息™（西他列汀）

INDICATIONS AND USAGE

适应症和用法

ZITUVIO™ is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

ZITUVIO™ 是一种二肽基肽酶-4（DPP-4）抑制剂，作为饮食和运动的辅助手段，可改善2型糖尿病成人的血糖控制。

Limitations of Use:

使用限制：

ZITUVIO™ is not recommended in patients with type 1 diabetes mellitus.

ZITUVIO™不推荐用于1型糖尿病患者。

ZITUVIO™ has not been studied in patients with a history of pancreatitis.

ZITUVIO™尚未对有胰腺炎病史的患者进行研究。

DOSAGE AND ADMINISTRATION

剂量和给药

The recommended dosage of ZITUVIO™ is 100 mg orally once daily. ZITUVIO™ can be taken with or without food.

ZITUVIO的推荐剂量™ 每天口服100毫克。ZITUVIO™可以带或不带食物。

Dosage adjustment is recommended for patients with eGFR less than 45 mL/min/1.73 m2.

对于eGFR小于45 mL/min/1.73 m2的患者，建议调整剂量。

Dosage Adjustment in Patients with Renal Impairment

肾功能不全患者的剂量调整

eGFR greater than or equal to 30 mL/min/1.73 m2 to less than 45 mL/min/1.73 m2

eGFR大于或等于30mL/min/1.73m 2至小于45mL/min/1.73m 2

eGFR less than 30 mL/min/1.73 m2 (including patients with end stage renal disease [ESRD] on dialysis)

eGFR小于30 mL/min/1.73 m2（包括透析时患有终末期肾病[ESRD]的患者）

50 mg once daily

50毫克，每天一次

25 mg once daily

25毫克，每天一次

DOSAGE FORMS AND STRENGTHS

剂型和强度

Tablets: 100 mg, 50 mg, and 25 mg

片剂：100毫克，50毫克和25毫克

CONTRAINDICATIONS

禁忌症

History of a serious hypersensitivity reaction to Sitagliptin or any of the excipients in ZITUVIO™, such as anaphylaxis or angioedema

对西他列汀或ZITUVIO中任何赋形剂发生严重超敏反应的历史™, 如过敏反应或血管性水肿

WARNINGS AND PRECAUTIONS

警告和注意事项

Pancreatitis: There have been post marketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue ZITUVIO™

胰腺炎：已有急性胰腺炎上市后报告，包括致命性和非致命性出血性或坏死性胰腺炎。如果怀疑胰腺炎，请立即停用ZITUVIO™

Heart failure: Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of ZITUVIO™ in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms.

心力衰竭：DPP-4抑制剂类的另外两名成员观察到心力衰竭。考虑ZITUVIO的风险和收益™在已知心力衰竭危险因素的患者中。监测患者的体征和症状。

Acute Renal Failure: Has been reported post marketing, sometimes requiring dialysis. Assessment of renal function is recommended prior to initiating ZITUVIO™ and periodically thereafter.

急性肾功能衰竭：上市后有报道，有时需要透析。建议在开始ZITUVIO之前评估肾功能™并在此后定期。

Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues: Increased risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Lower dose of insulin or insulin secretagogue may be required.

与胰岛素或胰岛素促分泌剂同时使用的低血糖症：当与胰岛素和/或胰岛素促分泌剂组合使用时，低血糖症的风险增加。可能需要较低剂量的胰岛素或胰岛素促分泌剂。

Hypersensitivity Reactions: There have been post marketing reports of serious allergic and hypersensitivity reactions in patients treated with Sitagliptin such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Promptly stop ZITUVIO™, assess for other potential causes, institute appropriate monitoring and treatment..

超敏反应：使用西他列汀治疗的患者出现严重过敏和超敏反应的上市后报告，如过敏反应，血管性水肿和包括史蒂文斯-约翰逊综合征在内的剥脱性皮肤病。立即停止ZITUVIO™, 评估其他潜在原因，进行适当的监测和治疗。。

Severe and Disabling Arthralgia: Has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if appropriate.

严重和致残性关节痛：据报道服用DPP-4抑制剂的患者。考虑作为严重关节疼痛的可能原因，并在适当时停用药物。

Bullous Pemphigoid: There have been post marketing reports requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue ZITUVIO™.

大疱性类天疱疮：已有上市后报告要求服用DPP-4抑制剂的患者住院治疗。告诉患者报告水疱或糜烂的发展。如果怀疑大疱性类天疱疮，请停用ZITUVIO™.

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SOURCE Zydus Lifesciences Limited

源Zydus Lifesciences Limited