Cipla receives final approval for generic version of Shire’s
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July 14, 2020: Cipla Limited 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.

Source: https://www.cipla.com/press-releases-statements/cipla-receives-final-usfda-approval-generic-version-shires-firazyr
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