USFDA gives nod for Granules’ anti-allergic product

Granules India on Tuesday said the US Food and Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by the company for Loratadine Tablets USP 10 mg (OTC).

The approved ANDA is the bioequivalent to the reference listed drug (RLD), Claritin Tablets 10 mg of Bayer Healthcare LLC. The product is an anti-allergic.

Announcing the USFDA approval for the ANDA, Granules India said it intended to commercialise the product shortly. Shares of the Hyderabad-headquartered drugmaker touched an intraday high of ₹129 before closing with a loss of 0.71% at ₹126.20 each.

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Printable version | Feb 28, 2020 9:41:33 AM | https://www.thehindu.com/news/cities/Hyderabad/usfda-gives-nod-for-granules-anti-allergic-product/article30390484.ece

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