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Alembic Pharma gets tentative USFDA nod for Ticagrelor tablets

Press Trust of India  |  New Delhi 

Drug firm has received tentative approval from the US health regulator for tablets, used to reduce the rate of cardiovascular death and in patients with (ACS) or a history of (MI).

"The company has got tentative approval from the (USFDA) to market the drug in the strength of 90 mg," said in a filing.

The tentatively approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to the reference listed (RLD), tablets of Pharmaceuticals LP.

Quoting IQVIA sales data, the company said, tablets, 90 mg had an estimated market size of USD 625 million for 12 months, ending December 2017.

The company said it now has a total of 75 ANDA approvals from the USFDA.

The company's stock was trading at Rs 540, up 1.71 per cent, on the

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Thu, July 12 2018. 11:20 IST