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Entreprise · 17/11/20231 min de lecture
Determination of Regulatory Review Period for Purposes of Patent Extension; ROZLYTREK INJECTION; Correction
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Résumé
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of July 8, 2022. The document announced the determination of the regulatory review period for ROZLYTREK INJECTION (entrectinib) for purposes of patent extension. The document was published with an incorrect dosage form. This notice corrects the dosage form of the drug product.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →