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Zuventus Gains CDSCO Approval for Edoxaban Tablets in India

The Central Drugs Standard Control Organisation (CDSCO) has given Zuventus Healthcare Limited permission to make and sell Edoxaban film-coated tablets in doses of 15 mg, 30 mg, and 60 mg. This is a big step forward for public health in India. The Subject Expert Committee (SEC) for Cardiology and Renal gave its approval. This is a very important step towards treating and preventing thromboembolic disorders in the country.

The SEC received Zuventus Healthcare Limited's bioequivalence (BE) study report on April 19, 2023, after a thorough examination. According to the committee, Edoxaban has a good profile. It works better than other non-vitamin K antagonist oral anticoagulants (NOACs), doesn't interact with proton pump inhibitors (PPIs), and has a lower risk of bleeding. Edoxaban's approval for use in the US, Japan, and Canada further bolstered the committee's confidence in its safety and efficacy.

While reviewing the drug, the SEC pointed out that Edoxaban could make a big difference in how well patients do in India, where heart disease, the risk of stroke, and other thromboembolic events are very common. Following extensive deliberation, the committee recommended granting manufacturing and marketing permissions, subject to Zuventus Healthcare conducting Phase IV clinical trials to ensure the drug's continued safety and effectiveness for the Indian population.

In order to get approval, Zuventus Healthcare has three months to send the Phase IV clinical trial protocol to the CDSCO. Once the drug receives approval, these studies will offer crucial insights into the practical clinical settings of Edoxaban. This will ensure that a diverse range of patients experience the benefits observed in controlled settings.

We expect the approval of Edoxaban to significantly impact India's public health issues, particularly those related to heart health. Edoxaban is a promising alternative to current blood thinners because it works better and has a lower risk of bleeding. It could help lower the number of strokes and other serious problems caused by thromboembolic disorders.

A lot of people, including doctors and patients, are excited about the new drug Edoxaban, which is a big step forward in anticoagulant therapy. Knowing that this medicine comes in different doses will make treatment plans more flexible and able to meet the unique needs of each patient.

Zuventus Healthcare Limited was able to get through the regulatory process, demonstrating how important thorough clinical evaluation is and how regulatory bodies protect public health. The company will continue to work with healthcare authorities to monitor and improve the use of Edoxaban as it moves forward in its Phase IV clinical trials. Make sure it meets the highest safety and effectiveness standards.

This approval shows that researchers, healthcare providers, and regulatory agencies in India are working together to make medical treatments and patient care better. 

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