Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Alogliptin Tablets, 6.25 mg, 12.5 mg and 25mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), NESINA Tablets, 6.25 mg, 12.5 mg and 25mg of Takeda Pharms USA.
Alogliptin Tablets, 6.25 mg, 12.5 mg and 25mg are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Alogliptin Tablets, 6.25 mg, 12.5 mg and 25mg has an estimated market size of $65.6 million for twelve months ending December 2017 according to IQVIA. Alembic now has a total of 78 ANDA approvals (64 final approvals and 14 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.