Aurobindo Pharma, Lupin and Jubilant Life Sciences get USFDA nod for hypertension drug

NEW DELHI: Three domestic firms, Aurobindo Pharma, Lupin and Jubilant Life Sciences, have received final approval from US health regulator to sell generic copies of Valsartan tablets used for treatment of hypertension.

The current annualised US market size for Valsartan tablets USP, 40 mg, 80 mg, 160 mg, and 320 mg as per IMS is around USD 2 billion, the pharma firms said.

While Lupin has launched the product in the US market already, Jubilant Life Sciences said it planned to launch the drug immediately. Aurobindo Pharma also said the product is ready for launch.

The companies have received final approval from the US Food and Drug Administration ( USFDA) for their abbreviated new drug applications for Valsartan tablets USP in multiple strengths of 40 mg, 80 mg, 160 mg and 320 mg, domestic firms said in separate statements.

The tablets are indicated for treatment of hypertension and are the generic versions of Novartis Pharmaceuticals Corporation's Diovan tablets.

Shares of Aurobindo Pharma closed down by 3.69 per cent at Rs 1,088.30, while Lupin fell 2.46 per cent to Rs 1,394.55 at close.

Jubilant Life Sciences, however, closed higher by 3.69 per cent at Rs 144.85.