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TITAN SARMS LLC – 719645 – 12/12/2025

Unapproved New Drugs

Maria A. Carballosa, M.D. – 720805 – 12/12/2025

In Vivo Bioavailability-Bioequivalence Studies – Clinical

Revive Rx LLC dba Revive Rx Pharmacy – 709509 – 09/22/2025

Compounding Pharmacy/Adulterated Drug Products

SV Labs Corporation – 716503 – 12/09/2025

CGMP/Finished Pharmaceuticals/Adulterated

Atomix LLC – 719111 – 12/12/2025

Unapproved New Drugs

FDA approves first prescription oral medicine for iron deficiency in pediatric patients ages 10 and older

The U.S. Food and Drug Administration (FDA) approved Accrufer (ferric maltol) capsules to treat pediatric patients ages 10 and older…

FDA approves drug to improve functional capacity and symptoms in adults with rare inherited heart condition

The U.S. Food and Drug Administration (FDA) approved Myqorzo (aficamten) tablets to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM)…

Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act

Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic…