The FDA has approved ISTA's supplemental New Drug Application (sNDA) for Xibrom (bromfenac topical ophthalmic solution) 0.09%, expanding Xibrom's indications to include the treatment of pain following cataract surgery. Xibrom, a topical, twice-daily NSAID, was originally approved by the FDA in March 2005 for the treatment of ocular inflammation following cataract surgery.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.