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Alembic Pharma gets tentative USFDA nod for Ticagrelor tablets

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Mumbai | Thursday, Jul 12 2018 IST
Pharma Major, Alembic Pharmaceuticals said that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abberivated New Drug Application(ANDA) Ticagrelor tablets 90 mg.

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

It is used to reduce the rate of cardiovascular death and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction (MI).

Quoting IQVIA sales data, the company said, Ticagrelor tablets, 90 mg had an estimated market size of USD625 million for 12 months, ending December 2017.

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

UNI JS NV SM SDR 1440

-- (UNI) -- C-1-DL0171-1435611.Xml

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