Granules India on Tuesday said the US health regulator had given its approval to the abbreviated new drug application filed by the drug firm for Loratadine tablets used to treat allergies.
“The US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules India Ltd, for Loratadine tablets USP, 10 mg (OTC),” Granules India said in a filing to BSE.
The approved ANDA is bioequivalent to the Reference Listed Drug (RLD), Claritin tablets 10 mg by Bayer HealthCare LLC, the filing said.
The company further said that it intends to commercialise this product “shortly“.
The shares of Granules India were trading at Rs 127.70, up 0.47 per cent on BSE in the morning trade.