Drug Approval | June 08, 2022
Lupin receives tentative approval from FDA for Ivacaftor tablets
Ivacaftor Tablets had estimated annual sales of USD 109 million in the US.
Ivacaftor Tablets had estimated annual sales of USD 109 million in the US.
The product will be launched by NATCO's commercial partner Viatris.
The Toradol tablets, 10 mg brand and generic had U.S. sales of approximately US $ 16.8 million MAT for the most recent twelve months ending in March 2022 according to IQVIA
The tablets have an estimated market size of US $ 548 million for twelve months ending December 2021 according to IQVIA
According to IQVIA sales data for the 12-month period ending March 2022, the Zytiga tablets, 500 mg market achieved annual sales of approximately US $ 260.2 million
The drug will be manufactured at the group's formulation facility at SEZ, Ahmedabad
The tablets are available in 100 mg strength in bottle count sizes of 60
This product will be manufactured at Lupin’s Nagpur facility in India
The product will be manufactured at Lupin’s facility in Goa, India
In May 2021, Daiichi Sankyo had submitted a supplemental new drug application (sNDA) for Tarlige tablets based on results from a phase 3 trial in patients with CNP
Subscribe To Our Newsletter & Stay Updated
