Novartis’ Aclasta gets second FDA approvable letter for Paget’s disease
Novartis said that it is confident that providing the requested additional information to the FDA will help obtain final approval by the end of 2006. Aclasta has already
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.