FDA actions in brief, March 2009 (Gelnique, RiaSTAP, Kapidex)

Elevidys is a gene therapy approved to treat Duchenne muscular dystrophy. Last month, Sarapta halted sales of the therapy for non-ambulatory patients.

Some vials in two lots of the antibiotic cefazolin are labeled as being penicillin G potassium, which if used could lead to suboptimal outcomes, adverse events, drug interactions and delayed recovery.

This new Shingrix vaccine presentation eliminates the need for reconstitution, simplifying the administration process for healthcare professionals.

Following in the footsteps of other pharmaceutical companies, Bristol Myers Squibb and Pfizer are offering Eliquis for cash-paying patients at a discount of 40% off the list price.

Leqselvi (deuruxolitinib) 8 mg tablets are approved for adults with severe alopecia areata, a disease that causes the immune system to attack hair follicles, leading to partial or complete hair loss on the scalp and body.

Kerendia was originally approved in July 2021 to reduce cardiovascular and kidney complications in patients with chronic kidney disease (CKD) associated with type 2 diabetes. This new approval extends its use to a broader patient population.