3 Indian firms get FDA nod to sell generic hypertension drug
07 Jan 2015
Three Indian drug firms - Aurobindo Pharma, Lupin, and Jubilant Life Sciences - have received final approval from the US Food and Drug Administration (FDA) to sell generic copies of Valsartan tablets used for treatment of hypertension.
The current annualised US market size for Valsartan tablets USP of 40 mg, 80 mg, 160 mg, and 320 mg is around $2 billion, the firms said.
While Lupin has launched the product in the US market already, Jubilant Life Sciences said it planned to launch the drug immediately, and Aurobindo Pharma also said the product is ready for launch.
The companies have received final approval from the FDA for their abbreviated new drug applications for Valsartan tablets in the same multiple strengths, the Indian 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.