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FDA Alerts

FDA New Drug Approvals: May 2023

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FDA approves oral antiviral medication for COVID-19 in adults
The FDa has granted approval to Paxlovid, an oral antiviral medication, for the treatment of mild-to-moderate COVID-19 in adults who are at a higher risk of developing severe symptoms or complications. Paxlovid consists of two tablets, nirmatrelvir and ritonavir, packaged together for oral use. It is the fourth drug to receive FDA approval for treating COVID-19 in adults and is the first oral antiviral pill to be authorized. The approval signifies a significant advancement in the available treatment options for COVID-19.

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FDA approves treatment for pneumonia caused by difficult-to-treat bacteria
The FDA has granted approval for Xacduro, a treatment for adults with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by a specific group of bacteria known as Acinetobacter baumannii-calcoaceticus complex. Xacduro consists of 2 components, sulbactam for injection and durlobactam for injection. This approval signifies a new option for combating these types of pneumonia in eligible patients.

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FDA approves fezolinetant for vasomotor symptoms caused by menopause
Astellas Pharma’s drug, Veozahtm (fezolinetant), has been approved by the FDA for the treatment of moderate to severe vasomotor symptoms (VMS) caused by menopause. It is the first nonhormonal neurokinin 3 (NK3) receptor antagonist to receive approval for this indication.

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FDA approves Elfabrio for Fabry disease
Chiesi Global Rare Diseases and Protalix BioTherapeutics have jointly announced that the FDA has granted approval for Elfabrio (pegunigalsidase alfa-iwxj) for the treatment of Fabry disease in adult patients. Chiesi Global Rare Diseases, a division of the Chiesi Group dedicated to providing innovative therapies for rare diseases, collaborated with Protalix BioTherapeutics, a biopharmaceutical company focused on developing and commercializing therapeutic proteins using their plant cell-based expression system called ProCellEx. This FDA approval represents a significant milestone in addressing the needs of adult patients with Fabry disease.

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