Business · 09/07/2007

Otsuka Pharmaceutical Co., Ltd. Withdraws Approval of New Drug Application for RAXAR Tablets Due to FDA Correction

The FDA is correcting a notice regarding the withdrawal of a new drug application for RAXAR (grepafloxacin hydrochloride (HCl)) Tablets, which was published with typographical errors, and is also removing the product from the FDA's Orange Book list of approved drug products.