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