CDSCO Panel Clears Sanofi's Updated Myozyme Insert, Seeks Revision on Administration Guidance
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended the approval of the updated Package Insert for Alglucosidase alfa (Myozyme 50 mg), a recombinant enzyme therapy manufactured by Sanofi Healthcare India Pvt Ltd.
However, the approval is subject to the inclusion of a critical safety instruction. The SEC has mandated that the following statement be added under Section 4.2 – Posology and Method of Administration:
“In case of any infusion-related reaction, if required, the patient should be transferred to a nearby hospital/clinical facility for treatment.”
In addition to this condition, the committee has directed the company to submit the revised Package Insert to CDSCO for further evaluation.
This recommendation follows Sanofi’s proposal for the approval of the Updated Package Insert (dated October 2024) for Myozyme 50 mg, which includes revisions in the following sections: Posology and Method of Administration, Special Warnings and Precautions for Use, Drug Interactions, Undesirable Effects, Overdose, Pharmacological Properties, Other administrative updates
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