FDA News

Opioid manufacturers will supply outpatient pharmacies and other dispensers with pre-paid mail-back envelopes for disposal of unused medication.

Narcan naloxone hydrochloride nasal spray 4 mg is expected to be available in-store and online by the late summer.

The rule change would provide flexibility in standards that govern specific ingredients used in food production, permitting replacement of regular sodium with less toxic substitutes.

The FDA's Antimicrobial Drugs Advisory Committee voted 16-1 to support the approval of Paxlovid for the treatment of of mild-to-moderate COVID-19 in adults at high risk for severe disease.

The FDA authorized Pfizer's bivalent vaccine as a booster dose for children aged under 5 years who received 3 doses of monovalent vaccine.

Beginning on Sept 24, 2024, all women must be notified of their breast density status in mammography reports and encouraged to pursue supplemental screening.

Zavegepant, the first FDA-approved intranasal CGRP receptor antagonist, could be available in pharmacies by July 2023.

The SGLT-2 inhibitor, if approved for this age group, would be the first agent in the class with the indication as adjunctive treatment for T2D for those younger than age 18.

The prescription remote electrical neuromodulation device is now cleared for both acute and preventive treatment of migraine in those aged ≥12 years, according to Theranica.

The VRBPAC vote that the GSK data support the vaccine's efficacy was unanimous and on safety the vote was 10-2. PDUFA date set for May, 2023.