FDA rejects Novartis ’ Advair generic, leaving GSK without rival

GlaxoSmithKline (NYSE:GSK) was granted a temporary win today after Novartis‘ (NYSE:NVS) Sandoz unit reported that the FDA rejected its application for a generic version of the company’s blockbuster lung treatment, Advair. The regulatory agency reportedly told Novartis that it needs to submit additional clinical data before the FDA can make its final decision. Get the full story at our sister site, Drug Delivery Business News. The post FDA rejects Novartis’ Advair generic, leaving GSK without rival appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Respiratory Wall Street Beat GlaxoSmithKline plc Novartis sandoz Source Type: news