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Negócios · 17/11/20231 min de leitura

Determination of Regulatory Review Period for Purposes of Patent Extension; ROZLYTREK INJECTION; Correction

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Resumo

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.

Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →

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