Zydus Cadila has received tentative nod from the US health regulator to market Glipizide tablets, used for the treatment of diabetes, in America.
“Zydus Cadila has received tentative approval from the United States Food and Drug Administration (USFDA) to market Glipizide extended release tablets in the strengths of 2.5 mg, 5 mg and 10 mg,” Zydus group’s listed entity, Cadila Healthcare, said in a filing to the BSE.
According to IMS Health, the estimated sales in 2014 for Glipizide ER tablets is $90.1 million, it added.
“The group now has 97 approvals and has so far filed 249 abbreviated new drug applications (ANDAs) since the commencement of the filing process in 2003-2004,” Cadila Healthcare said.
Shares of Cadila Healthcare were trading 0.30 per cent up at Rs 1,291.20 per scrip in the afternoon on the BSE.