Articles related to DEVICE/DRUG APPROVALS

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).

Clinical trials of abaloparatide, a human parathyroid hormone related peptide analog, showed significantly increased bone mineral density at 12 months in the lumbar spine and femoral neck in men with osteoporosis.

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.

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.

The decision to remove Lumoxiti from the US market was attributable to its extremely poor clinical uptake because there were other treatment choices available, according to AstraZeneca’s letter to healthcare professionals. Its limited uptake may also have been caused by the complicated administration, the requirement for toxicity prophylaxis, and the need for safety monitoring. The elimination has nothing to do with the drug’s efficacy or safety.

Sunlenca (lenacapavir), which comes in 300 mg tablets and a 463.5 mg/1.5 mL injection, provides doctors with a long-needed twice-yearly option for patients with complicated past treatment histories who would otherwise have few treatment options.