Glucocorticoid Inj Permanently Discontinued

At this time, no further information has been provided regarding the discontinuation
At this time, no further information has been provided regarding the discontinuation

The Food and Drug Administration (FDA) is informing about the permanent discontinuation of Aristospan (triamcinolone hexacetonide injectable suspension;Sandoz) 20mg/mL.

Aristospan Intra-Articular is a glucocorticoid indicated as adjunctive therapy for short-term administration in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis

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Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Naturally occurring glucocorticoids, which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. The synthetic analogs are primarily used for their anti-inflammatory effects in disorders of many organ systems. When injected intra-articularly, triamcinolone hexacetonide can be expected to be absorbed slowly from the injection site.

Aristospan Intra-Articular 20mg/mL is supplied in 2mL (NDC 0781-3085-71) and 10mL (NDC 0781-3085-75) vials.  At this time, no further information has been provided regarding the discontinuation.

For more information call (888) 463-6332 or visit FDA.gov

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