DynamicLevels
DynamicLevels
05 Jul 2016
Alembic recieves USFDA tentative approval for FEBUXOSTAT
Dynamic Levels
Today, Alembic pharma announced that the company has acquired the tentative approval from the US Food and Drug Administration (USFDA) for its ANDA, i.e, Abbreviated New Drug Application for 40 mg and 80 mg febuxostat tablets. The approved ANDA is therapeutically equal to the Reference Listed Drug Product, or RLD, of USA's Takeda Pharma's 40 mg and 80 mg of Uloric tablets. Febuxostat is indicated for the chronic management of hyperuricemia in patients with gout.
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