CDSCO approves Abbott's proposal for Protocol Amendment of Triamcinolone Hexacetonide study
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol amendment proposal for the inclusion of 40 mg dose of Triamcinolone Hexatonide injectable suspension USP presented by the drug major Abbott for the synthetic glucocorticoid corticosteroid Triamcinolone hexacetonide.
This came after Abbott presented the amendment in Phase-IV clinical trial protocol for the inclusion of a 40 mg dose of Triamcinolone Hexatonide injectable suspension USP.
Triamcinolone hexacetonide also known as triamcinolone acetonide 21-tebutate is a synthetic glucocorticoid corticosteroid.
Triamcinolone is a medication used to manage and treat various conditions such as atopic dermatitis, contact dermatitis (e.g., poison ivy), eczema, bullous dermatitis, herpetiform psoriasis, lichen planus, lichen sclerosis, subacute cutaneous lupus erythematosus, dermatomyositis, and seasonal or allergic rhinitis.
Triamcinolone hexacetonide binds to specific cytosolic glucocorticoid receptors and subsequently interacts with glucocorticoid receptor response elements on DNA and alters gene expression.
At the recent SEC meeting for Analgesic and Rheumatology held on 3rd April 2024, the expert panel reviewed the proposal presented by the drug major Abbott for the Phase IV protocol amendment for the inclusion of a 40 mg dose of Triamcinolone Hexatonide injectable suspension USP.
After detailed deliberation, the committee recommended a grant of permission to amend the Phase IV clinical trial protocol from protocol No. TRIA-422-0200, version 3.0 dated 08.11.2022 to protocol No. TRIA-422- 0200, version 4.0 dated 14.12.2023.
