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 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.
The company must submit the proposed prescribing information and relevant literature or supporting data.
Author's summary: Abbott must provide prescribing details and data.