B. Braun Medical, Inc.; Withdrawal of Approval of Abbreviated New Drug Application of Hydroxyethyl Starch

摘要

The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) BA110013/0032 for 6 Percent Hydroxyethyl Starch 130/0.4 in 0.9 Percent Sodium Chloride Injection in EXCEL[supreg] Plastic Container, held by B. Braun Medical, Inc. B. Braun Medical, Inc., requested in writing that the Agency's approval of the application be withdrawn because the drug is no longer being marketed and has waived its opportunity for a hearing.