Drug Approval | September 22, 2022
Shilpa Medicare receives tentative approval for Tenofovir Alafenamide Tablets
The ANDA was filed as 'First to File' submission on NCE-1 date.
The ANDA was filed as 'First to File' submission on NCE-1 date.
Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery
Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).
According to industry sales data, Yondelis generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.
Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive
Ivacaftor Tablets had estimated annual sales of USD 109 million in the US.
The drug will be manufactured at the group's formulation facility at SEZ, Ahmedabad
Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US $ 102 million for twelve months ending December 2021 according to IQVIA
This product will be manufactured at Lupin’s Nagpur facility in India
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Pradaxa Capsules of Boehringer lngelheim
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