Biocon gets USFDA nod for generic product
- This 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 said in a statement
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Biocon Pharma Ltd, a subsidiary of Biocon, has received received approval of its ANDA for Mycophenolic Acid from the US drug regulator.
"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.
This 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 said in a statement.
On Thursday, Biocon shares were down 1% to close at ₹367 apiece on NSE.