Alembic Pharmaceuticals has received tentative approval from the US health regulator for Ticagrelor tablets, used to reduce the rate of cardiovascular death and stroke in patients with acute coronary syndrome or a history of myocardial infarction.
“The company has got tentative approval from the US Food and Drug Administration (USFDA) to market the drug in the strength of 90 mg,” Alembic Pharmaceuticals said in a BSE filing today.
The tentatively approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product, Brilinta tablets of Astrazeneca Pharmaceuticals LP.
Quoting IQVIA sales data, the company said, Ticagrelor tablets, 90 mg had an estimated market size of $625 million for the 12 months, ended December 2017. The company now has got 75 ANDA approvals from the USFDA.
Alembic Pharma stock was trading at Rs 540, up 1.71 per cent, on the BSE.
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.