Drugs

Paxlovid Widely Available in Pharmacies: Farley

Pfizer’s Covid-19 treatment Paxlovid (nirmatrelvir tablets and ritonavir tablets) is now widely available in community pharmacies and is authorized for treating mild-to-moderate Covid-19 in adults and pediatric patients age 12 and older with positive results of direct SARS-CoV-2 viral testing who are also at high risk for progression to severe Covid-19, including hospitalization or death. In a CDER Conversation, Office of Infectious Diseases director John Farley answers these questions about Paxlovid for healthcare providers:

what does “direct SARS-CoV- viral testing” mean and do patients need a positive PCR test to be treated with Paxlovid;
how should healthcare providers assess a patient for ‘high risk for progression to severe Covid-19”;
are there tools to help healthcare providers manage potential drug-drug interactions;
is dose adjustment of Paxlovid needed for patients with moderate renal impairment;
how can a community pharmacy that has Paxlovid in stock be located; and
what is known about case reports of patients developing symptoms after completing a course of Paxlovid.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome