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Negócios · 09/12/20211 min de leitura
Fresenius Kabi Deutschland GmbH; Withdrawal of Approval of New Drug Application of Hydroxyethyl Starch
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Resumo
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 Fresenius Kabi Deutschland GmbH requested in writing that the Agency's approval of the application be withdrawn because the drug is no longer being marketed and has waived its opportunity for a hearing.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →