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 directed 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 was issued after a detailed review of the company’s proposal during the SEC meeting held 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 (Single Dose) for use in already approved indications, along with a detailed justification of the rationale and clinical need for this new pre-filled syringe presentation of the drug.
Author's summary: Abbott must submit prescribing details and data.