Biocon Pharma gets US FDA approval for Everolimus tablets

Biocon said its wholly owned arm Biocon Pharma has received approval from the US Food and Drug Administration for its abbreviated new drug application for Everolimus tablets for oral suspension.

The approval covers 2 mg, 3 mg, and 5 mg strengths. Everolimus tablets for oral suspension are used to treat adult and paediatric patients aged one year and above with tuberous sclerosis complex who have subependymal giant cell astrocytoma. The drug is also approved as an add-on therapy for partial-onset seizures linked to tuberous sclerosis complex in patients aged two years and above.

Biocon said the approval will further strengthen its portfolio of vertically integrated drug products.