Drug Approval | August 29, 2022
Lupin receives tentative approval from USFDA for Dasatinib Tablets
Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).
Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD 1569 million in the U.S. (IQVIA MAT June 2022).
he approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US. LLC (Sanofi).
Desvenlafaxine Extended-Release Tablets, 25 mg is a generic equivalent of Pristiq Extended-Release Tablets, 25 mg of PF PRISM C.V.
JB Pharma is the fastest growing pharmaceutical company in FY 2021-22 and Q1 of FY 2022-23.
Formoterol Fumarate Inhalation Solution (RLD Perforomist) had estimated annual sales of US $282 million in the US
The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
The product will be manufactured at Lupin's facility in Goa, India.
The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.
Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.
The product will be manufactured at Lupin’s facility in Goa, India.
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