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.
Camber's generic Quelicin is used as an adjunct to general anesthesia, to facilitate tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.