What were the reasons for discontinuing Asacol HD (Mesalamine)? Asacol HD (Mesalamine)

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What were the reasons for discontinuing Asacol HD (Mesalamine)? Asacol HD (Mesalamine)

For U.S. market discontinuation of Asacol HD 800 mg, the key point is: FDA determined it was not discontinued because of safety or effectiveness problems. AbbVie/Allergan notified FDA on May 13, 2022 that Asacol HD was being discontinued, and FDA moved it to the Orange Book’s “Discontinued Drug Product List.” In February 2023, FDA reviewed records, literature, and postmarketing adverse-event data and found no information indicating withdrawal for safety or effectiveness reasons.

So the publicly documented reason is essentially manufacturer discontinuation for reasons other than safety or efficacy. FDA’s notice does not give a more specific commercial reason, such as profitability, supply, or strategy. Drugs.com’s 2026 generic-availability page also lists the FDA-approved Asacol HD 800 mg formulation as discontinued.

A common source of confusion: older Asacol 400 mg was handled differently. FDA withdrew approval for Asacol 400 mg because it contained dibutyl phthalate (DBP) as an inactive ingredient, and FDA had concerns about phthalate exposure, especially in vulnerable populations. FDA records note that Asacol HD later received a phthalate-free formulation approval in May 2016, so that DBP issue is not the stated reason for the later Asacol HD market discontinuation.

Separately, if you meant why a patient might be told to stop taking Asacol HD, the label lists clinical reasons such as suspected mesalamine acute intolerance syndrome, hypersensitivity reactions, severe skin reactions, renal impairment concerns, hepatic failure risk in patients with liver disease, or significant adverse reactions. In trials, adverse-reaction discontinuations occurred in 3.9% of Asacol HD patients, most commonly due to gastrointestinal symptoms associated with ulcerative colitis.

Status: Open Nov 28, 2024 - 10:26 AM

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What were the reasons for discontinuing Asacol HD (Mesalamine)? Asacol HD (Mesalamine)

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