Business · 14/06/2007

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

Otsuka Pharmaceutical Co., Ltd. has voluntarily withdrawn FDA approval of its new drug application for RAXAR (grepafloxacin hydrochloride (HCl)) Tablets, citing that the product is no longer commercially available, thus waiving the opportunity for a public hearing.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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