Abbott Told to Provide Prescribing Details, Supporting Data for Triamcinolone Hexacetonide Pre-Filled Syringe

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.