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Aurobindo's subsidiary Eugia Pharma Specialities receives final approval from US FDA

Aurobindo's subsidiary Eugia Pharma Specialities receives final approval from US FDA

Aurobindo Pharma’s subsidiary Eugia Pharma Specialities has received final approval from the US Food and Drug Administration to manufacture and market the cancer drug Lenalidomide Capsules, in different strengths.

The approved product is bioequivalent and therapeutically equivalent to the reference listed drug, Revlimid Capsules, of Bristol-Myers Squibb Company. It is indicated for the treatment of adult patients with multiple myeloma, in combination with Dexamethasone.

Aurobindo Pharma said the product is expected to be launched in October and it will be a volume-specific launch.

This is the 155th abbreviated new drug application (ANDA), including nine tentative approvals, received, out of Eugia Pharma Speciality Group facilities, manufacturing both oral and sterile speciality products, the company said.

More news about: quality / gmp | Published by Sudeep Soparkar | March - 11 - 2023 | 759

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