XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). Semaglutide acts as a glucagon-like peptide-1 (GLP-1) receptor agonist, mimicking the GLP-1 hormone released in the gastrointestinal tract after eating.

FDA Approval 98

FDA Approval Containment Drugs Pharmacy 98

XTalks

SEPTEMBER 28, 2023

One of the reasons behind this gap is the US Food and Drug Administration’s (FDA) “ generally recognized as safe ” — or GRAS — designation. The Environmental Working Group (EWG) identified several food products containing this chemical, such as Entenmann’s Coconut Crunch Donuts and Sara Lee Honey Glazed Buns.

Hormones 52

Hormones Containment Production Cosmetics 52

FDA Law Blog

AUGUST 4, 2023

DASCA amended the CSA by revising and adding specified substances to the definition of “anabolic steroid,” providing for the temporary and permanent scheduling of anabolic steroids and adding labeling requirements for products containing anabolic steroids. DASCA became law, amending the CSA, on December 18, 2014.

Hormones 52

Hormones Manufacturing Regulation Drugs 52

Pfizer

AUGUST 15, 2022

One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course. Drugs listed in this section are a guide and not considered a comprehensive list of all drugs that may be contraindicated with PAXLOVID.

Drugs 99

Drugs Vaccination Vaccine In-Vitro 99

Pfizer

DECEMBER 20, 2022

FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets).

Drugs 69

Drugs Licensing Licensing Containment 69

Pfizer

DECEMBER 13, 2022

In June of 2022, Pfizer submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID for patients who are at high risk of progression to severe disease from COVID-19. The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is in February 2023.

Drugs 110

Drugs Licensing Licensing Production 110

XTalks

AUGUST 2, 2023

Pfizer’s Top 5 Best-Selling Drugs of 2022: 1) Comirnaty Comirnaty is an mRNA-based vaccine indicated for the prevention of COVID-19. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir.

Sales 98

Sales Manufacturing FDA Approval Life Science 98