GSK Reviews FDA Proposed Label Changes
GSK and makers of the other affected medicines containing LABAs have 30 days to agree with the proposed changes or state why they are not warranted. The FDA’s
The US Food and Drug Administration (FDA) is set to review Kowa Pharmaceuticals America’s new drug application (NDA) for K-911, an investigational once-daily eye drop aimed at reducing intraocular pressure (IOP) in open-angle glaucoma (OAG) or ocular hypertension (OHT) patients.