Drug Approval | October 05, 2022
Lupin receives approval from USFDA for Darunavir Tablets
The product will be manufactured at Lupin's facility in Nagpur, India.
The product will be manufactured at Lupin's facility in Nagpur, India.
Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of US $2.4 billion in US
The companies will leverage their respective proprietary technology platforms
Diclofenac Sodium Topical Solution USP, 2% w/w (RLD Pennsaid) had estimated annual sales of US $484 million in the US
Depending on the type of cancer, it can be used as monotherapy or combination as a part of first line regimen, maintenance regimen or relapsed settings
Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of US $37 million for twelve months ending June, 2022 according to IQVIA
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).
Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).
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