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.
In the CRL, the FDA stated that a satisfactory inspection is required before the NDA can be approved.
Entadfi is a fixed-dose combination of finasteride, a 5α-reductase inhibitor, and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor.
Gemtesa is an oral, once-daily, small molecule beta-3 adrenergic agonist.
Kyzatrex is an investigational, oral testosterone undecanoate softgel that utilizes lymphatic absorption and phytosterols to increase bioavailability and provide a favorable pharmacokinetic profile.
A recent Morbidity and Mortality Weekly Report (MMWR) highlights the risks associated with use of over-the-counter (OTC) products containing undeclared prescription ingredients as well as the importance of collaboration between various health departments and systems to ensure a prompt response to an outbreak.
The FDA has approved a new version of Axonics Modulation’s rechargeable implantable sacral neurostimulator (r-SNM) system that allows patients to decrease the frequency of charging to once a month.
The FDA has granted Fast Track designation for empagliflozin (Jardiance; Boehringer Ingelheim and Lilly) to reduce the risk of kidney disease progression and cardiovascular (CV) death in adults with chronic kidney disease.
The combination of cefepime, a cephalosporin antibiotic, and enmetazobactam, a novel extended-spectrum β-lactamase inhibitor (Exblifep; Allecra Therapeutics) was found to be superior to piperacillin-tazobactam in the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis, according to top-line results from the phase 3 ALLIUM trial. The double-blind, non-inferiority study included 1034 patients randomized to…
Theraworx® Protect U-Pak (Avadim Health), a hygiene solution developed to address risk factors associated with recurrent urinary tract infections (UTIs), is now available in retail pharmacies.
