Lupin Pharma gets tentative approval for Hepatitis B drug.
Global pharma major Lupin Limited today announced that it has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) Ivacaftor Tablets, 150 mg. The approval allows Lupin to market a generic equivalent of Kalydeco Tablets, 150 mg of Vertex Pharmaceuticals Incorporated. As per the company, the product will be manufactured at Lupin’s Nagpur facility in India. According to IQVIA MAT March 2022, the Ivacaftor Tablets had estimated annual sales of $109 million in the US. Last…