Biocon arm gets USFDA nod for generic Everolimus tablets

Biocon Ltd on Monday said its arm Biocon Pharma Ltd has received approval from the US health regulator for its generic version of Everolimus tablets for oral suspension used in the treatment of tuberous sclerosis complex, a rare genetic disease that causes non-cancerous tumors or lesions in different parts of the body.

The approval granted by the US Food and Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) for Everolimus tablets for oral suspension in 2 mg, 3 mg and 5 mg strengths, Biocon Ltd said in a regulatory filing.

The approval will further strengthen Biocon's portfolio of vertically integrated drug products, it added.


Everolimus tablets for oral suspension are indicated for the treatment of adult and pediatric patients aged 1 year and above with Tuberous Sclerosis Complex (TSC) who have subependymal giant cell astrocytoma.

It is also indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures, the company said.