The FDA works with many people and groups, such as patients, caregivers, and drug and device manufactures, to support rare disease product development.
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Hunter Holmes McGuire Veterans Admin Medical Center, Richmond, VA 483 Issued 3/11/2015Denver Solutions, LLC. Englewood, CO. 483 issued 12/11/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 12/11/2025
Short Title (70 char) Denver Solutions, LLC. Englewood, CO. 483 issued 12/11/2025
FEI Number 3013438582
Firm Name Denver Solutions, LLC
Record Type 483
State CO
Establishment Type Outsourcing FacilityFDA requires expanded labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHD
The U.S. Food and Drug Administration (FDA) is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD) – including certain formulations of amphetamine and methylphenidate – to warn about the risk of weight loss and other adverse rea