FDA News

The FDA action ends the use of monovalent COVID-19 mRNA vaccines from Pfizer/BioNTech and Moderna in favor of bivalent formulations to simplify the vaccination schedule, said the Agency.

Although the number of dispensed opioid prescriptions has somewhat declined, overdose deaths involving opioids continue to rise. The FDA is requiring stronger warnings of risk.

To be marketed as Rizafilm, the product is a disintegrating film formulation of the 5-HT-1 receptor antagonist and proven bioequivalent to Merck's Maxalt-MLT.

Ensitrelvir fast track status is supported by phase 3 study findings showing resolution of COVID-19 symptoms a full day earlier in those taking the drug vs placebo.

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.