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).
The directive followed 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 Triamcinolone Hexacetonide Injectable Suspension USP 40 mg/2 ml Pre-filled Syringe for use in already approved indications, along with a detailed justification of the rationale and clinical need for this new presentation.
Abbott must provide prescribing information and data for the new pre-filled syringe.
Author summary: Abbott directed to submit data for Triamcinolone Hexacetonide.