Alembic Pharmaceuticals Limited today announced that the company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ticagrelor Tablets, 90 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Brilinta Tablets, 90 rng, of Astrazeneca Pharmaceuticals LP. Ticagrelor tablets are indicated to reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction (MI).
Ticagrelor Tablets, 90 mg have an estimated market size of US$ 625 million for twelve months ending December 2017 according to IQVIA.
Alembic now has a total of 75 ANDA approvals (65 final approvals and 10 tentative approvals) from USFDA.
Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.531 as compared to the previous close of Rs. 517.25. The total number of shares traded during the day was 5510 in over 298 trades.
The stock hit an intraday high of Rs. 534.95 and intraday low of 514.7. The net turnover during the day was Rs. 2898837.