Sept 4 (Reuters) - The U.S. Drug Enforcement
Administration (DEA) has increased the production limit for
Takeda Pharmaceutical's ( TAK ) ADHD drug Vyvanse and its
generic versions by about 24% to address the medicine's ongoing
shortage in the United States.
The raised production limit follows the Food and Drug
Administration's request in July, the DEA said in a notice on
Tuesday.
Attention deficit hyperactivity disorder (ADHD) drugs have
been in short supply for years. The FDA warned of a shortage of
Israel-based drugmaker Teva Pharmaceutical Industries'
Adderall in October 2022, troubled by manufacturing delays.
That led to a spike in demand and subsequent shortage of
Takeda's Vyvanse.
Vyvanse, also known as lisdexamfetamine, is classified by
the DEA as a schedule II controlled substance, which is applied
to drugs considered to have a high likelihood of being abused,
and additional prescribing safeguards are put in place.
The production limit for lisdexamfetamine was increased by
6,236 kilograms (kg), which includes 1,558 kg to address
increased domestic demand and 4,678 kg for increased foreign
demand for finished dosage medications, according to the DEA.
"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," DEA said.
US FDA approved generic versions of Vyvanse from 11
drugmakers, including U.S.-based drugmakers Mallinckrodt ( MCKPF ) and
Viatris ( VTRS ), UK-based Hikma Pharmaceuticals ( HKMPF ), and
Indian drugmaker Sun Pharmaceutical Industries, last
year after Takeda lost exclusivity over the drug.
Bloomberg News first reported about the increased limits on
Tuesday.