Mumbai, Oct 16 (UNI) Pharma Major,Alembic Pharmaceuticals Limited
said that company 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, company said in afiling with BSE.
Alogliptin Tablets, 6.25 mg, 12.5mg and 25mg are indicated as an
adjunct to diet and exercise to improve glycemic control in adults
with type 2 diabetes mellitus.
Alogliptin Tabiets, 6.25 mg, 12.5 mg and 25mg has an estimated
market size of US$ 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.