Subject: FDA
Zydus receives USFDA approval for ZITUVIOtm to treat adult patients with type 2 diabetes mellitus
The company received final approval from the USFDA for its New Drug Application (NDA) for ZITUVIOtm (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg
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 ZITUVIOtm (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg.
ZITUVIOtm 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.
The approval of ZITUVIOtm is based on research, development, regulatory and manufacturing work performed by Zydus teams. ZITUVIOtm has undergone quality testing for Nitrosamines and potential genotoxic impurities as per current USFDA standards. ZITUVIOtm is compliant with current USFDA standards of Nitrosamines in Sitagliptin containing products.
"The ZITUVIOtm 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.
"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. Punit Patel, CEO of Zydus Pharmaceuticals, Americas.
According to IQVIAtm (MAT Aug-2023), U.S. market for DPP-IV inhibitors and its combinations is US$ 10 bn.
About 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. The group aspires to transform lives through pathbreaking discoveries. For more details visit www.zyduslife.com.
IMPORTANT SAFETY INFORMATION FOR ZITUVIOtm (Sitagliptin)
INDICATIONS AND USAGE
ZITUVIOtm 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.
Limitations of Use:
- ZITUVIOtm is not recommended in patients with type 1 diabetes mellitus.
- ZITUVIOtm has not been studied in patients with a history of pancreatitis.
DOSAGE AND ADMINISTRATION
The recommended dosage of ZITUVIOtm is 100 mg orally once daily. ZITUVIOtm can be taken with or without food.
Dosage adjustment is recommended for patients with eGFR less than 45 mL/min/1.73 m2.
Dosage Adjustment in Patients with Renal Impairment | |
eGFR greater than or equal to 30 mL/min/1.73 m2 to less than 45 mL/min/1.73 m2 | eGFR less than 30 mL/min/1.73 m2 (including patients with end stage renal disease [ESRD] on dialysis) |
50 mg once daily | 25 mg once daily |
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg, 50 mg, and 25 mg
CONTRAINDICATIONS
History of a serious hypersensitivity reaction to Sitagliptin or any of the excipients in ZITUVIOtm, such as anaphylaxis or angioedema
WARNINGS AND PRECAUTIONS
- 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 ZITUVIOtm
- Heart failure: Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of ZITUVIOtm in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms.
- Acute Renal Failure: Has been reported post marketing, sometimes requiring dialysis. Assessment of renal function is recommended prior to initiating ZITUVIOtm and periodically thereafter.
- 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.
- 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 ZITUVIOtm, assess for other potential causes, institute appropriate monitoring and treatment.
- 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.
- 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 ZITUVIOtm.
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SOURCE Zydus Lifesciences Limited
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