• Cipla Receives Final Approval for Generic Version of Shire’s Firazyr®

    • July 15, 2020
    • Posted By : admin
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    Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) and hereafter referred to as (“Cipla”) today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Icatibant Injectable 30mg/3mL from the United States Food and Drug Administration (US FDA).

    Cipla’s Icatibant Injectable Pre-Filled Syringe 30mg/3mL is AP-rated generic version of Shire’s Firazyr®. Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

    According to IQVIA (IMS Health), Firazyr® and its generic equivalents had US sales of approximately $270M for the 12-month period ending May 2020.

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