Biocon arm gets USFDA nod for chronic heart failure drug Sacubitril/Valsartan
Bangalore: Biocon has announced that Biocon Pharma Limited, a wholly owned subsidiary of the Company, has received approval of its Abbreviated New Drug Administration (ANDA) for Sacubitril/Valsartan Tablets, in 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg strengths, from the U.S Food and Drug Administration (US FDA).
Sacubitril and valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and hospitalization. This medicine is also used to treat paediatric patients over the age of one year.
The approval further adds to Biocon’s portfolio of vertically integrated, complex drug products.
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Biocon Limited, publicly listed in 2004, is an innovation-led, global biopharmaceutical company. It has developed and commercialized novel biologics, biosimilars and complex small molecule APIs in India and several key global markets, as well as generic formulations in the US and Europe.
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