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Cipla gets USFDA nod for Icatibant Injectable

Anthony Fernandes
/ Categories: DSIJ Mindshare, DSIJ News
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Cipla gets USFDA nod for Icatibant Injectable

On Tuesday, pharma major Cipla Limited declared that it has been granted approval for its Abbreviated New Drug Application (ANDA) for Icatibant Injectable 30mg/3mL by United States Food and Drug Administration (USFDA).

Cipla's Icatibant Injectable pre-filled syringe 30mg/3mL is an AP-rated generic version of Shire's Firazyr and is used to treat acute attacks of hereditary angioedema (HAE) in adults.

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

Cipla Limited is a pharmaceutical company which offers products for therapeutic areas, including cardiovascular, dermatology & cosmetology, children's health, HIV/AIDS, diabetes, infectious diseases and critical care, malaria, oncology, neurosciences, osteoporosis, ophthalmology, respiratory, urology and women's health. The company manufactures dry powder inhalers, metered dose inhalers, nebulisers, nasal sprays and a range of inhaled accessory devices.

In response to the announcement, Cipla Limited's stock was trading at Rs 639.15 at 11 a.m. on Tuesday, up by 0.16 per cent or Rs 1 per share. The 52-week high is Rs 696 and the 52-week low is recorded at Rs 356.75 on BSE.

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