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The company has received tentative approval from the United States Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Dabigatran Etexilate Capsules, 150 mg.
The tentative approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) PRADAXA Dabigatran Etexilate Mesylate Capsules, Eq to 150 mg base, Boehringer Ingelheim.
Dabigatran Etexilate Capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep vanous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5 to 10 days.
It is also indicated to reduce the risk of recurrence of DVT and PE in patients who have been previously treated.
BUY ALEMBIC PHARMACEUTICALS LTD.
The company has received tentative approval from the United States Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Dabigatran Etexilate Capsules, 150 mg.
The tentative approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) PRADAXA Dabigatran Etexilate Mesylate Capsules, Eq to 150 mg base, Boehringer Ingelheim.
Dabigatran Etexilate Capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep vanous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5 to 10 days.
It is also indicated to reduce the risk of recurrence of DVT and PE in patients who have been previously treated.
According
to IMS, Dabigatran Etexilate Capsules, 150 mg have an estimated market
size of USD 726.3 million for 12 months ending December 2016.
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Alembic Pharmaceuticals Ltd
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Chirayu Amin
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Pranav Amin
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