Biocon Limited announced that its wholly owned subsidiary, Biocon Pharma Limited, has received approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets for Oral Suspension in 2 mg, 3 mg, and 5 mg strengths.

Everolimus Tablets for Oral Suspension are indicated for the treatment of adult and pediatric patients aged 1 year and older with Tuberous Sclerosis Complex (TSC) who have Subependymal Giant Cell Astrocytoma (SEGA). Additionally, it is approved for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures.

This U.S. FDA approval is expected to further strengthen Biocon's portfolio of vertically integrated drug products.