Abbott Directed to Provide Prescribing Details for Triamcinolone Hexacetonide Pre-Filled Syringe
The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has instructed Abbott Healthcare Pvt. to submit proposed prescribing information and supporting data for Triamcinolone Hexacetonide Injectable Suspension USP 40 mg/2 ml Pre-filled Syringe.
This directive follows a detailed review of the company's proposal during the SEC meeting on September 17, 2025, at CDSCO headquarters in New Delhi. Abbott presented its proposal for introducing the pre-filled syringe for use in already approved indications, along with a justification for the new presentation.
The firm submitted a detailed justification of the rationale and clinical need for this new pre-filled syringe presentation of the drug.
Autor summary: Abbott must provide data for new syringe.
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