Biocon has received approval from the US Food and Drug Administration (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 paediatric patients aged one year and older with Tuberous Sclerosis Complex (TSC) who have Subependymal Giant Cell Astrocytoma (SEGA), and for the adjunctive treatment of adult and paediatric patients aged two years and older with TSC-associated partial-onset seizures.

The approval will further strengthen Biocon’s portfolio of vertically integrated drug products.