CDSCO Panel Approves Updated Prescribing Information for AstraZeneca's Rosuvastatin (Crestor)

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-06-08 07:13 GMT | Update On 2025-06-08 07:13 GMT

New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted approval for the updated Prescribing Information of Rosuvastatin Calcium Tablets IP 5mg, 10mg, 20mg, and 40mg (Crestor), marketed by AstraZeneca Pharma India Limited.

The decision came following AstraZeneca’s presentation of proposed updates to Version 6 and 7 of the drug’s Prescribing Information before the expert panel during the SEC (Cardiovascular) meeting held on April 9, 2025.

Rosuvastatin belongs to a class of drugs known as HMG-CoA reductase inhibitors (statins). It works by inhibiting an enzyme responsible for cholesterol production in the liver, thereby lowering LDL (bad cholesterol) and triglycerides, while increasing HDL (good cholesterol). The medication is commonly prescribed to prevent cardiovascular events such as heart attacks and strokes in at-risk patients.

After detailed deliberation, the committee recommended approval of the updated prescribing details as presented by the company.

Also Read: CDSCO Panel Approves BE Study for Alkem's Dapagliflozin, Pioglitazone, Metformin FDC, Seeks Revised Phase III Plan

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Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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CDSCO Panel Approves Updated Prescribing Information for AstraZeneca's Rosuvastatin (Crestor)

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