USFDA gives final nod to Alembic Pharmaceuticals’ chemotherapy capsules | The Financial Express

USFDA gives final nod to Alembic Pharmaceuticals’ chemotherapy capsules

Cyclophosphamide Capsules are a medication used as chemotherapy and to suppress the immune system.

USFDA gives final nod to Alembic Pharmaceuticals’ chemotherapy capsules
The health regulator's decision is in line with an advisory panel's recommendation to not approve the drug. (File)

Alembic Pharmaceuticals Limited on Monday announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Cyclophosphamide Capsules, 25 mg and 50 mg.

Cyclophosphamide Capsules are a medication used as chemotherapy and to suppress the immune system. It is indicated to treat various types of cancer like lymphoma, multiple myeloma, leukemia, ovarian cancer, breast cancer, small cell lung cancer, neuroblastoma, and sarcoma.

It is also indicated to minimally change nephrotic syndrome in pediatric patients.

According to a press statement, the approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cyclophosphamide Capsules, 25 mg and 50 mg of Hikma Pharmaceuticals USA Inc.

Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market size of US$ 8 million for twelve months ending Sep 2022 according to IQVIA.

Alembic has a cumulative total of 176 ANDA approvals (152 final approvals and 24 tentative approvals) from the USFDA.

ALSO READ | Alembic Pharma Q2 PAT dips 19% Y-O-Y; Revenue up 14% to Rs. 1475 crores

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First published on: 14-11-2022 at 11:11 IST