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pharmanewsdaily

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Cipla gets FDA’s final approval for generic version of Migranal with CGT designation

Cipla has secured final approval for its abbreviated new drug application (ANDA) for Dihydroergotamine Mesylate Nasal Spray 4mg/mL from the US Food and Drug Administration (FDA) with a competitive generic therapy (CGT) designation. The Indian pharma company said that it is the first approved applicant for such CGT and as a result is eligible for […]
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Quidel’s Lyra Direct SARS-CoV-2 Assay gets FDA EUA status for molecular detection of COVID-19

Quidel has been given emergency use authorization from the US Food and Drug Administration (FDA) for its Lyra Direct SARS-CoV-2 Assay to be used for the molecular detection of COVID-19. According to the diagnostic healthcare products manufacturer, the EUA status enables the Lyra Direct SARS-CoV-2 Assay for carrying out direct sample processing without the extraction […]