Entreprise · 23/12/20021 min de lecture
SoloPak Laboratories, Inc.; Withdrawal of Approval of 1 New Drug Application and 38 Abbreviated New Drug Applications; Correction
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Résumé
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 21, 1999 (64 FR 33097; corrected July 19, 1999 (64 FR 38675)). The document, which announced the withdrawal of approval of 1 new drug application (NDA) and 38 abbeviated new drug applications held by SoloPak Laboratories, Inc., inadvertently withdrew approval of NDA 19-961 for Ganite (gallium nitrate). FDA has subsequently learned that SoloPak, at the time it requested withdrawal of this NDA, was not its holder. Therefore, SoloPak was not authorized to make such a request. FDA confirms that approval of NDA 19-961, currently held by Genta, Inc., is still in effect.