October 29, 2015
Published on October 27, 2015, the guidance document outlines a number of recommendations for the nonclinical evaluation of previously approved drug substances when a new formulation or a new route...
October 12, 2015
FDA’s priority review voucher program allows drug makers to receive expedited review of drug products intended to treat rare or neglected diseases (more details in our blog post here). The program...
October 5, 2015
Sandoz, the generic pharmaceuticals division of Novartis, is the global leader in biosimilar products. On March 6, 2015, FDA approved Zarxio, a biosimilar version of Amgen’s Neupogen (filgrastim)...
September 15, 2015
FDA has accepted for review the first NDA for a “digital” medicine product. The product, which is produced by Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health, is the first-ever medication...
April 9, 2015
On February 25, 2015, FDA approved Toujeo, a once-daily, long-acting recombinant insulin. A year earlier an inhaled formulation of insulin, Afrezza, was approved. These recent additions to the...
April 22, 2014
Following extensive marketing of Lovenox® (enoxaparin sodium), a low-molecular weight heparin, a number of biosimilar versions of enoxaparin and one ANDA-approved formulation (enoxaparin sodium,...