Lupin receives tentative USFDA nod for generic Azilsartan Medoxomil tablets

Homegrown pharmaceuticals major Lupin on Friday said it has received tentative approval from the US health regulator for its generic Azilsartan Medoxomil tablets used to treat high blood pressure.

The tentative approval by the US Food and Drug Administration (USFDA) for the abbreviated new drug application (ANDA) Azilsartan Medoxomil tablets is for strengths of 40 mg and 80 mg, Lupin said in a regulatory filing.

These are generic equivalent of Edarbi tablets, 40 mg and 80 mg of Arbor Pharmaceuticals, LW, it added.

"This product will be manufactured at Lupin's Nagpur facility in India," the company said. Citing IQVIA moving annual total (MAT) September 2021 data, the company said the Azilsartan Medoxomil tablets had estimated annual sales of USD 103.4 million in the US.