FDA News and Regulatory Updates

The wearable tubeless insulin delivery device provides a fixed rate of continuous long-acting insulin for 72 hours, requiring no needles or injections.

The oral calcitonin gene-related peptide receptor antagonist is now indicated for prevention in both episodic and chronic migraine.

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.

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.

The first-of-its kind combination home-based test matched lab-based PCR tests for identification of influenza A and B and COVID-19.

Pfizer will present pivotal phase 3 data for RSVpreF to the ACIP on February 23; FDA has set a PDUFA date for the vaccine candidate of August 2023.

The novel oral agent is administered once daily for 14 days and has demonstrated rapid and sustained improvement in symptoms across trials.

The approval offers patients the choice to administer the monoclonal antibody at home using a prefilled device or to continue to receive it in a clinical setting.

The FDA and CDC must adopt the VRBPAC recommendation before it can be considered for implementation.

The FDA wants clinicians to avoid using the neutralizing antibody as it appears to be less effective against newer circulating strains of the SARS-CoV-2 virus.

Bexagliflozin significantly improved glycemic control in adults when used as monotherapy, in combination with metformin, or when added to several SOC regimens.

The update removes a previous limitation that stated semaglutide should not be used as an initial therapy for treating patients with T2D.

Get a quick look at 15 of the many FDA-approved drugs in 2022 for conditions commonly seen in primary care.