Brian Park, PharmD

These products are used as lubricant eye drops and are being recalled out of an abundance of caution due to a risk for bacterial and fungal contamination.

Donanemab is an investigational antibody therapy that targets a modified form of deposited amyloid-β peptide called N3pG.

The approval was based on data from two phase 3 studies, which included patients 12 years of age and older with nonsegmental vitiligo who had depigmented areas.

Eli-cel is an investigational one-time gene therapy designed to add functional copies of the ABCD1 gene into a patient’s own hematopoietic stem cells.

Tlando is supplied as 112.5mg of testosterone undecanoate capsules.

The application included data from the phase 2 BEYOND study.

The EMPRISE study assessed the efficacy and safety of empagliflozin use in approximately 500,000 adults with type 2 diabetes.

The FDA extended the action date by 3 months to allow more time to review additional analyses of data from the Company’s clinical studies.

The study enrolled women who completed the 24-week LIBERTY 1 and 2 studies and the 28-week open-label extension studies, and who met the definition of a responder.

Byooviz (ranibizumab-nuna) is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.