USFDA

Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as Zydus) has received final approval from the United States Food and Drug Administration (USFDA) to market Dapsone Gel, 7.5%, (USRLD : Aczone® Gel 7.5%). 

Dapsone Gel is used to treat acne and will be manufactured at the group’s topical manufacturing facility at Changodar, Ahmedabad (India). 

Dapsone Gel, 7.5% had annual sales of USD 35.8 mn in the United States (IQVIA MAT March 24).

The Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

FDA's Center for Drug Evaluation and Research (CDER) announced the launch of the CDER Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to promote CDER clinical trial innovation activities through enhanced communication and collaboration, both internally within CDER and externally.