Home Health Coronavirus (COVID-19) Update: Daily Roundup August 28, 2020 – FDA.gov

Coronavirus (COVID-19) Update: Daily Roundup August 28, 2020 – FDA.gov

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For Immediate Release:

The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:

  • The FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9% sodium chloride injection (ANDA 212571), indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting as well as the sedation of non-intubated patients prior to and/or during surgical and other procedures. The most common side effects of dexmedetomidine hydrochloride injection are hypotension (low blood pressure), bradycardia (slow heart rate), and dry mouth. This drug is included in the FDA’s Drug Shortage Database. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to medical products to help address…



Read More: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-august-28-2020

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Source: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-august-28-2020

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