USA – FDA approves 948 generic drug applications in 2020

The US Food and Drug Administration (FDA) approved or tentatively approved 948 generic drug applications in 2020, with a significant portion aimed at potential treatments and supportive therapies for patients with COVID-19, according to the annual report from FDA’s Office of Generic Drugs (OGD).
 
In response to the pandemic, OGD devised a system for identifying generic drugs with the potential to treat COVID-19 and accelerating those assessments, according to OGD’s Director Sally Choe, PhD. “This system for identifying generic drugs to address the COVID-19 public health emergency involved establishing infrastructure and resolving assessment issues to support prompt actions involving critically-needed generic drugs,” she wrote.
 
Those accelerated generic products included antibiotics, sedatives for ventilated patients, anticoagulants, and pulmonary medications, according to FDA.
 
Outside of responding to the COVID-19 public health emergency, OGD boasted approval of 72 “first generics,” as well as 30 generics under the Competitive Generic Therapy pathway…