The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CRESEMBA as approved under new drug application (NDA) 207500 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product as approved under NDA 207500.
Document
Determination of Regulatory Review Period for Purposes of Patent Extension; CRESEMBA-New Drug Aapplication 207500
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CRESEMBA as approved under new drug application (NDA) 207500 and is publishi...
Legal Citation
Federal Register Citation
Use this for formal legal and research references to the published document.
83 FR 4221
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Determination of Regulatory Review Period for Purposes of Patent Extension; CRESEMBA-New Drug Aapplication 207500,” thefederalregister.org (January 30, 2018), https://thefederalregister.org/documents/2018-01645/determination-of-regulatory-review-period-for-purposes-of-patent-extension-cresemba-new-drug-aapplication-207500.