Advair Diskus has a market value of approximately $3 billion for the 12 months ended February 2021, although actual generic market values are expected to be lower.
The tentative approval applies to the chronic lymphocytic leukemia/small lymphocytic lymphoma treatment in strengths of 560 mg, 420 mg, 280 mg, and 140 mg.
Janet Woodcock will share the latest FDA actions on quality initiatives, supply chain integrity, inspections during COVID-19, GDUFA III and BsUFA III, and innovation in the generic and biosimilars industry.