FDA Listing of Authorized Generics
FDA Listing of Authorized Generics
FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer
On April 8, 2025, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb Company) with ipilimumab (Yervoy, Bristol Myers Squibb Company)…
Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due to a Label Mix-up
Golden State Medical Supply, Incorporated (GSMS, Inc.) – Camarillo, CA has initiated a voluntary recall of the products listed in…
Patient-Focused Drug Development
The OCE PFDD program fosters collaboration between FDA centers and external stakeholders involved in patient outcomes research in cancer populations.
www.thesafepills.org – 702942 – 03/27/2025
Unapproved New Drugs/Misbranded
Evaluating the Early Operational Performance of the Endocrine Module in the Athlete Biological Passport
The International Testing Agency, in collaboration with various Anti-Doping Organisations and the Paris WADA-accredited laboratory, led the Endocrine Module’s implementation…
Ozempen.com – 684435 – 06/24/2024
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
Sun Pharmaceutical Industries Limited – 677337 – 06/18/2024
CGMP/Finished Pharmaceuticals/Adulterated
Premier Manufacturing Products, LLC – 678912 – 07/02/2024
Finished Pharmaceuticals/Unapproved New Drug
Sports Supplement Analysis Survey for the Prevalence of WADA Prohibited Substances in the Australian Online Marketplace
A survey of 200 sports supplements purchased online in Australia and analysed for WADA Prohibited Substances. Athlete education regarding the…