US regulatory nod for Strides anti-allergy drug

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.

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.

--IANS
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