The Drug firm Alembic Pharmaceuticals said it has received approval from the US health regulator for Febuxostat tablets. These tablets lower high levels of uric acid in adults who have gout. The approved product is therapeutically equivalent to the reference listed drug Uloric tablets of Takeda Pharmaceuticals U.S.A., Inc.
This company has also received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Febuxostat tablets in the strengths of 40 mg and 80 mg, the company revealed the information in a
filing to BSE. Quoting IQVIA data, Alembic Pharma said Febuxostat tablets have an expected market size of USD 578 million for a year finishing December 2018.
It further adds that the company has a total of 98 ANDA approvals (87 final approvals and 11 tentative approvals) from USFDA. Earlier, Alembic had received tentative approval for this ANDA from the US health regulator.