US regulatory nod for Strides’ anti-allergy drug

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Bengaluru, July 24 (IANS) Pharma company Strides Shasun Ltd on Monday said that the US Food and Drug Administration (USFDA) has approved marketing of its anti-allergy drug in the US.

It said they had received approval from the USFDA for manufacturing their Cetirizine Softgel liquid-filled capsules of 10 mg in Bengaluru and marketing them in the US, the firm said in a statement here.

Cetirizine is an anti-histamine used to relieve allergy symptoms such as watery eyes, runny nose, itching eyes/nose, sneezing, hives, and itching.

According to the American market research firm IRI data, the US market for the Cetirizine capsules is about $60 million.

“We are the first Indian generic firm to receive the US regulatory approval for manufacturing and marketing the anti-allergy drug,” said the company.

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The approval came after the recent regulatory inspection of the company’s Bengaluru production facility.

“The product is ready for launch. As in the case of OTC (over the counter) products, the market formation takes time, we expect to have a significant market share in six months,” it added.



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