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March 4, 2025

TKTX USA – 698435 – 02/25/2025

Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER February 25, 2025 RE: 698435 Dear Sir/Madam: This letter concerns your […]
March 4, 2025

Chem-Tech, Ltd. – 696920 – 02/11/2025

Delivery Method: VIA EMAIL WITH READ RECEIPT Reference #: 320-25-44 Product: Drugs Recipient: Recipient Name Mr. Jason Archer Recipient Title General Manager Chem-Tech, Ltd. 1006 Business […]
February 28, 2025

FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use

FDA reviewed five observational studies4-8 and two meta-analyses of placebo-controlled trials9,10 to examine the risk of cardiovascular events associated with testosterone replacement therapy (TRT). The five […]
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