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İş dünyası · 09.12.20211 dk okuma
Fresenius Kabi Deutschland GmbH; Withdrawal of Approval of New Drug Application of Hydroxyethyl Starch
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Özet
The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) BN 070012/0022 for VOLUVEN (6 Percent Hydroxyethyl Starch 130/0.4 in 0.9 Percent Sodium Chloride Injection), held by Fresenius Kabi Deutschland GmbH. Fresenius Kabi Deutschland GmbH requested in writing that the Agency's approval of the application be withdrawn because the drug is no longer being marketed and has waived its opportunity for a hearing.
Kaynağın orijinal dili: Federal Register — Food and Drug AdministrationOrijinal duyuruyu açın →