United States: Pharmacy’s attention has been focused on how Shire, the maker of the ADHD drug Vyvanse, has been granted permission by the U. S. Drug Enforcement Administration to produce more of the medicine as the shortage in the critical drugs remains rife.
After the US Food and Drug administration had asked DEA in July, DEA said on Thursday, Takeda Pharmaceuticals may increase its production limit by up to 24%.
Addressing Critical Supply Issues
As reported by Health Day, the DEA said in the notice it posted on the approval, “These adjustments are necessary to guarantee that the good [lisdexamfetamine or Vyvanse] is available in sufficient quantities and without interruption both for legitimate US patients and worldwide.”
Background on the Shortage
Chronic shortage of ADHD drugs has been evident for several years. The FDA issued the first alert on the shortage or short supply of of the Teva Pharmaceutical Industries’ Adderall in October, 2022, when the company experienced manufacturing issues.
This led to a rise in its demand as well as scarcity of the Takeda’s Vyvanse drug in the market.
Why was the DEA’s approval to increase production required? Like Adderall, which contains mixed amphetamine salts, Vyvanse (lisdexamfetamine) is a schedule II drug according to the DEA; a classification given to drugs that are likely to be abused hence extra measures on prescribing are place.
DEA’s Regulatory Measures
The DEA said that the production limit of lisdexamfetamine was raised by 13, 478 pounds (6,236 kilograms) that includes 3,434 pounds (1,558 kg) for domestic utilization and 10,313 pounds (4,678 kg) to export finished dosage medicines. Last year after Takeda lost exclusivity on Vyvanse.
Generic Alternatives
The FDA approved generic versions of Vyvanse from eleven manufacturers including Mallinckrodt and Viatris in U. S., Hikma Pharmaceuticals in the UK, and Sun Pharmaceutical Industries in India, according to sources from Reuters.