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Cipla receives USFDA nod for Firazyr generic

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The drug major on Tuesday (14 July) said it received final approval for its abbreviated new drug application (ANDA) for Icatibant injectable from the United States Food and Drug Administration (USFDA).

Cipla's Icatibant injectable pre-filled syringe is AP-rated generic version of Shire's Firazyr. It 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 $270 million for the 12-month period ending May 2020.

Meanwhile, Cipla on Monday (13 July) announced that the discussions to renegotiate the deal between Cipla's US subsidiary CipTech and Pulmatrix Inc for the co-development and commercialization of antifungal drug Pulmazole, are now in progress. The renegotiated agreement may include, amongst other things a reallocation of costs and a grant of rights to CipTec to develop and commercialize Pulmazole in select markets outside the United States, Cipla said in a regulatory filing.

Cipla is a global pharmaceutical company focused on complex generics, and deepening portfolio in India, South Africa, North America, and key regulated and emerging markets.

On a consolidated basis, the drug maker's net profit declined 33% to Rs 245.95 crore on a 0.7% rise in net sales to Rs 4301.60 crore in Q4 March 2020 over Q4 March 2019.

The scrip rose 0.72% to trade at Rs 642.75 on the BSE. It has traded in the range of Rs 639 and Rs 642.85 so far during the day.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

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First Published: Tue, July 14 2020. 09:18 IST
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