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In a significant move to mitigate the ongoing shortage of ADHD medications in the U.S., the Drug Enforcement Administration (DEA) has authorized a substantial increase in the production limits for Takeda Pharmaceutical Co Ltd’s (NYSE:TAK) Vyvanse and its generic versions.
Following the FDA’s request in July, the production of Vyvanse, known chemically as lisdexamfetamine, will increase by 24%. This decision addresses not only the domestic shortfall but also the rising international demand.
The shortage of ADHD drugs, notably Vyvanse and Adderall, a product of Israel-based Teva Pharmaceutical Industries Ltd (NYSE:TEVA), has been exacerbated by manufacturing delays and a spike in demand.
Recognized by the DEA as a Schedule II controlled substance, lisdexamfetamine requires additional prescribing safeguards due to its high potential for abuse.
The DEA’s recent production adjustment includes an additional 6,236 kilograms of lisdexamfetamine, divided into 1,558 kilograms to meet the increased U.S. demand and 4,678 kilograms for international markets.
“These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine to meet legitimate patient needs both domestically and globally,” stated the DEA.
Further bolstering the supply chain, Reuters highlighted the FDA last year approved generic versions of Vyvanse from 11 drug manufacturers, including U.S.-based Mallinckrodt Plc (OTC:MCKPF) (OTC:MNKTQ) and Viatris Inc (NASDAQ:VTRS), UK-based Hikma Pharmaceuticals Plc, (OTC:HKMPF) (OTC:HKMPY) and Indian drugmaker Sun Pharmaceutical Industries.
These approvals came after Takeda’s exclusivity on the drug ended, opening the market to more players and potentially stabilizing supply.
Price Action: TAK shares are down by 0.10% to $14.91 at the last check on Friday.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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