The U.S. Food and Drug Administration (FDA) approved Palsonify (paltusotine) tablets to treat adults with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.
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Approved active drugs with sponsors to which FDA has granted exclusivity for pediatric studies under Section 505A of the Federal Food, Drug, and Cosmetic Act (FD&C Act)Fresenius Kabi Compounding LLC. Canton, MA. 483 issued 11/05/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/05/2025
Short Title (70 char) Fresenius Kabi Compounding LLC. Canton, MA. 483 issued 11/05/2025
FEI Number 3013438665
Firm Name Fresenius Kabi Compounding LLC
Record Type 483
State MA
Establishment Type OutsoGeneric Drug Research Publications & Resources
The results of research studies conducted GDUFA initiatives provide new tools for FDA to evaluate generic drug equivalence.