Abbott Told to Provide Prescribing Details, Supporting Data for Triamcinolone Hexacetonide Pre-Filled Syringe
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has directed Abbott Healthcare Pvt. Ltd. to submit the proposed prescribing information (PI) and relevant literature or 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.
During the meeting, 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. The firm also submitted a detailed justification of the rationale and clinical need for this new pre-filled syringe presentation of the drug.
After examining the data and presentation, the committee recommended that the firm submit the proposed prescribing information (PI) specifying the usage of the pre-filled syringe in particular indications and age groups, along with supporting literature, studies, and data. The recommendation aims to ensure that the new single-dose presentation aligns with the approved therapeutic indications and safety parameters already established for Triamcinolone Hexacetonide.
Triamcinolone Hexacetonide is a long-acting corticosteroid used for intra-articular and soft-tissue injections to manage inflammatory and rheumatic conditions such as arthritis and bursitis. The new pre-filled syringe format, proposed by Abbott, is intended to enhance ease of administration and ensure accurate single-dose delivery in clinical settings.
Abbott Healthcare Pvt. Ltd., is engaged in developing and marketing various therapeutic products across multiple specialties, including rheumatology and pain management.
