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Back in August 2023, we reported the approval of a significant number of lisdexamfetamine ANDAs that are expected to alleviate ongoing shortages (here). But today, the FDA reported that lisdexamfetamine capsule products are once again in trouble ( here ). There are 11 companies on the drug shortage list for lisdexamfetamine dimesylate capsules, but he is the only two to report availability in all product strengths. Nine of the companies have varying degrees of limited availability or product allocation, active ingredients are not available, some products will be available in February 2024, or We are reporting that the product is currently not available at all. .

When we first reported this issue, there was uncertainty about how the market would react to a long list of new approvals and how they would impact previous critical shortages. I noticed that. Well, these approvals may be short-lived as most of the inventory and replacement inventory released after the August ANDA approval has likely been swallowed up by pent-up demand, and companies are still struggling to keep up with demand. Seems like a good solution. Again, this is bad news for patients who rely on this product for treatment.

Continued pressure on this market, the Drug Enforcement Administration, and manufacturers will certainly increase rapidly as supply continues its apparent downward cycle. There are also reports that patients are hoarding medicines due to the shortage, making the problem even worse. We'll have to see what happens over the next few months.

 

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