FDA gives Glenmark 2nd tentative nod for generic Onglyza

Glenmark has received a second tentative approval from the Food and Drug Administration for saxagliptin tablets, 2.5 mg and 5 mg, the generic version of AstraZeneca’s Onglyza.

Generic Onglyza is used with diet and exercise to lower blood sugar in adults with Type 2 diabetes.

[Read more: Glenmark launches generic Bumex]

Glenmark received its first tentative approval for generic Onglyza on June 12, 2017.

Onglyza tablets have a market value of approximately $122.3 million for the 12-month period ending December 2022, according to IQVIA.

[Read more: Glenmark expands OTC portfolio with acquisition of Wockhardt’s ANDAs]