FDA Approves Oral Testosterone Replacement Therapy Kyzatrex
The FDA has approved Kyzatrex (testosterone undecanoate) for the treatment of primary and secondary hypogonadism in adult males.
Urologic Disorders
Bludigo Approved as Diagnostic Dye for Cystoscopic Assessment of Ureters
The approval was based on data from a phase 3 study that included 118 adults undergoing endoscopic urological or gynecological surgical procedures.
FDA Cracks Down on Honey-Based Products Tainted With Undeclared Drugs
The products were being promoted and sold for sexual enhancement on various websites and online marketplaces, and possibly in some retail stores.
FDA Needs More Data on Tebipenem HBr for Complicated UTI
In the CRL, the FDA stated that the application could not be approved in its present form and that an additional clinical trial would be required.
FDA Approves Oral Testosterone Replacement Therapy Tlando
The approval was based on data from a phase 3 study that evaluated the efficacy and safety of Tlando in 95 adult hypogonadal male patients.
Positive Efficacy Findings Prompt Early Stop of Empagliflozin CKD Trial
The EMPA-KIDNEY study enrolled more than 6600 patients with CKD attributable to a wide range of underlying causes.
More Data Needed to Make Decision on Bardoxolone in Alport Syndrome
The CRL stated that the application for bardoxolone could not be approved in its current form due to a lack of data supporting claims of slowing kidney function loss and reducing kidney failure progression.
FDA Clears First Condom Indicated for Anal Intercourse
The FDA authorization was based on efficacy and safety data from a clinical trial that included 252 men who have sex with men and 252 men who have sex with women.
Tebipenem HBr Gets Priority Review for Oral Treatment of Complicated UTI
The application includes data from the phase 3 ADAPT-PO trial, which evaluated the efficacy and safety of tebipenem HBr in 868 adults with cUTI or acute pyelonephritis.
Entadfi Approved for Benign Prostatic Hyperplasia
Entadfi is a fixed-dose combination of finasteride, a 5α-reductase inhibitor, and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor.
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