Articles related to FDA

The SGLT2 inhibitor bexagliflozin is now available under the brand name Brenzavvy. Approval was based on monotherapy trials versus glimepiride, where the new drug was non-inferior, and in combination with metformin.

Emzahh (norethindrone tablets), the progestin-only generic equivalent of the discontinued Ortho Micronor, was approved via an abbreviated NDA.

The modified Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program eliminates the requirement for in-person dispensing and replaces it with a requirement that pharmacies dispense the drug be certified. Mifepristone, a progestin antagonist, may now be dispensed by or under the supervision of a certified prescriber, or by a certified pharmacy on a prescription issued by a certified prescriber, for medical termination of pregnancy up to 10 weeks gestation (70 days or less since the first day of the last menstrual period).

The adenoviral vector–based gene therapy contains the gene for interferon alfa-2b. It is administered by catheter into the bladder once every three months. The virus penetrates the bladder endothelial cells and releases the gene, which is incorporated by the cells. As a result, the cells begin secreting high levels of the cancer-fighting interferon.

Reports on the Vaccine Safety Datalink flagged the need to investigate a potential increased risk those 65 years of age and older, for ischemic stroke in the first 21 days after receiving the bivalent Pfizer-BioNTech booster. FDA has parallel monitoring systems to confirm or fail to validate a safety signal. In this case, those other systems did not confirm the Vaccine Safety Datalink flag.

Approved? Not-approved? What is “tentative approval?” Clinical trial data on this novel “once nightly” sodium oxibate showed the drug to be acceptable for narcolepsy. But legal issues are holding up the FDA approval process.