Biocon gets US FDA nod for generic product
The product is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant and is available in 180 mg and 360 mg strengths
Biocon yesterday said its unit has received approval from the US health regulator to market a generic product.
Biocon Pharma has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Mycophenolic Acid, the company said in a regulatory filing. ANDA is data to submit to the US FDA for approval of new generic medicines.
The product is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant and is available in 180 mg and 360 mg strengths.
This approval further adds to Biocon’s portfolio of vertically integrated complex drug products, the company noted.
Edits by EP News Bureau
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