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US allows increased production of Takeda's ADHD drug and its generics to address shortage
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US allows increased production of Takeda's ADHD drug and its generics to address shortage
Sep 6, 2024 5:32 AM

Sept 4 (Reuters) - The U.S. Drug Enforcement

Administration has increased the production limit for Takeda

Pharmaceutical's ( TAK ) ADHD drug Vyvanse and its generic

versions by about 24% to address the ongoing shortage of the

copies 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, 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.

The 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.

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