Alembic Pharma Gets USFDA Tentative Nod for Alogliptin Tab | CORPORATE ETHOS

Alembic Pharma Gets USFDA Tentative Nod for Alogliptin Tab

By: | October 16, 2018
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Oct 16: Drug maker Alembic Pharmaceuticals Ltd on Tuesday announced that the 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.

According to the company, 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 the 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.