In a major transfer to mitigate the continued scarcity of ADHD drugs within the U.S., the Drug Enforcement Administration (DEA) has approved a considerable enhance within the manufacturing limits for Takeda Pharmaceutical Co Ltd’s TAK Vyvanse and its generic variations.
Following the FDA’s request in July, the manufacturing of Vyvanse, recognized chemically as lisdexamfetamine, will enhance by 24%. This choice addresses not solely the home shortfall but in addition the rising worldwide demand.
The scarcity of ADHD medicine, notably Vyvanse and Adderall, a product of Israel-based Teva Pharmaceutical Industries Ltd TEVA, has been exacerbated by manufacturing delays and a spike in demand.
Acknowledged by the DEA as a Schedule II managed substance, lisdexamfetamine requires extra prescribing safeguards on account of its excessive potential for abuse.
The DEA’s latest manufacturing adjustment consists of a further 6,236 kilograms of lisdexamfetamine, divided into 1,558 kilograms to fulfill the elevated U.S. demand and 4,678 kilograms for worldwide markets.
“These changes are needed to make sure that the US has an sufficient and uninterrupted provide of lisdexamfetamine to fulfill professional affected person wants each domestically and globally,” stated the DEA.
Additional bolstering the provision chain, Reuters highlighted the FDA final yr authorised generic variations of Vyvanse from 11 drug producers, together with U.S.-based Mallinckrodt Plc MCKPF MNKTQ and Viatris Inc VTRS, UK-based Hikma Prescribed drugs Plc, HKMPF HKMPY and Indian drugmaker Solar Pharmaceutical Industries.
These approvals got here after Takeda’s exclusivity on the drug ended, opening the market to extra gamers and doubtlessly stabilizing provide.
Worth Motion: TAK shares are down by 0.10% to $14.91 on the final test on Friday.
Disclaimer: This content material was partially produced with the assistance of AI instruments and was reviewed and printed by Benzinga editors.
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