Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 75 mg and 150 mg and Tentative approval for Dabigatran Etexilate Capsules, 110 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 75 mg, 110 mg, and 150 mg of Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer). Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients; treatment and reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients. Refer label for a detailed indication.
Alembic Generic Dabigatran Etexilate Mesylate Receives Tentative Approval in US
Alembic Generic Dabigatran Etexilate Mesylate Receives Approval in US
Accord Healthcare`s Dabigatran Etexilate Receives Approval in the Europe
Enforcement Report - Week of April 5, 2023
FOR IMMEDIATE RELEASE- Parsippany. New Jersey. Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etcxilate Capsules. USP 75 mg and 150 mg to the consumer/user level due to the presence of a nitrosamine. N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level. To date, Ascend Laboratories LLC., has not received any reports of adverse events related to this recall.
BERLIN, Conn. , April 22, 2022 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted tentative approval of its Abbreviated New Drug Application for Dabigatran Etexilate Capsules (generic for Pradaxa®). This product development was a collaboration between Towa Pharmaceutical Europe, S.L. coupled with an external contract manufacturing organization. Breckenridge has the three strengths consistent with the brand – 75mg, 110mg, and 150mg. According to industry sales data, Pradaxa generated annual sales of $455 million during the twelve months ending February 2022.
Alembic Pharms` Generic Dabigatran Etexilate Mesylate Receives Approval in the U.S.
Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for formoterol fumarate inhalation solution, 20 mcg/2 mL per unit-dose vial.
Alembic Pharmaceuticals yesterday announced that it has received ntentative approval from the US Food and Drug Administration (FDA) for nits Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate nCapsules, 150 mg. The tentatively approved ANDA is therapeutically nequivalent to the Reference Listed Drug (RLD) product Pradaxa DabigatrannEtexilate Mesylate capsules, Eq to 150 mg base, Boehringer Ingelheim, nthe company said in a statement.