AstraZeneca Faces Setback as CDSCO Panel Rejects Seloken XL Prescribing Update
New Delhi: Rejecting the proposal of AstraZeneca Pharma for the update of prescribing information (PI) of Metoprolol Succinate Prolonged Release Tablets I.P. 25, 50, 100 and 200 mg (Seloken XL), the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has asked the firm to present proposed changes and differences in the proposed PI in comparison with approved PI in the USA and EU, along with the justification for the proposed changes.
The matter was earlier discussed in the SEC meeting held on January 28, 2025, where AstraZeneca Pharma presented the proposal for the update of prescribing information of Metoprolol Succinate Prolonged Release Tablets I.P. 25, 50, 100 and 200 mg (Seloken XL) with respect to warning conditions, PK/PD properties, overdose, contraindications, etc., based on the Company Core Data Sheet.
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Responding to this, the expert panel had asked the company to furnish additional data, published literature, or approved prescribing information from other countries.
Now, in continuous, at the recent SEC meeting for Cardiovascular, the firm has presented PI updates of Sweden and Australia only.
In addition, the firm had informed that they divested their product in the USA and Europe and failed to present the PI in the USA and Europe.
Metoprolol is a beta-1-adrenergic receptor inhibitor specific to cardiac cells with negligible effect on beta-2 receptors. This inhibition decreases cardiac output by producing negative chronotropic and inotropic effects without presenting activity towards membrane stabilization nor intrinsic sympathomimetics.
Seloken XL Tablet belongs to a group of medicines called beta-blockers. It is used to treat high blood pressure (hypertension), angina (heart-related chest pain), and irregular heart rhythms (arrhythmia). It also helps prevent migraines, future heart attacks, and strokes.
In view of the above, the Committee did not consider the proposal of the firm for the update of prescribing information of Metoprolol Succinate Prolonged Release Tablets I.P. 25, 50, 100, and 200 mg (Seloken XL).
The Committee asked the firm to present proposed changes and differences in the proposed PI in comparison with approved PI in USA and EU, along with the justification for the proposed changes.
