Biocon gets USFDA nod for generic product

Biocon Pharma, a subsidiary of the company, has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Mycophenolic Acid, the company said in a regulatory filing.

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Biotechnology major Biocon on Thursday said its unit has received approval from the US health regulator to market a generic product.

Biocon Pharma, a subsidiary of the company, has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Mycophenolic Acid, the company said in a regulatory filing.

The product is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant and is available in 180mg and 360mg strengths.

This approval further adds to Biocon’s portfolio of vertically integrated complex drug products, the company noted.

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