Biocon arm secures USFDA approval for Everolimus Tablets for prophylaxis of organ rejection in adult patients
Bangalore: Biocon Limited has announced that Biocon Pharma Limited, a wholly owned subsidiary of the Company, has received approval from the U.S. Food and Drugs Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets in strengths of 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg.
Everolimus is a prescription medication that is indicated for the prophylaxis of organ rejection in adult patients, and in kidney and liver transplantation.
The approval will further strengthen Biocon’s portfolio of vertically integrated, complex drug products.
Read also: Biocon Biologics, Civica join hands to expand Insulin Aspart access in US
Medical Dialogues has recently also reported that the U.S. Food and Drug Administration (U.S. FDA) has approved Biocon Biologics's Jobevne (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use.
Read also: Biocon Pharma gets USFDA approval for BP-raising injection in adults with acute hypotension
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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