Biocon Pharma's Milestone: USFDA Approval for Generic Everolimus

Biocon Pharma Ltd, a branch of Biocon Ltd, announced a significant achievement on Monday: obtaining USFDA approval for its generic version of Everolimus tablets, designed for oral suspension. These tablets are pivotal in managing tuberous sclerosis complex, a rare genetic disorder causing benign tumors across various body parts.

The US Food and Drug Administration has specifically approved the Abbreviated New Drug Application (ANDA) for this formulation in strengths of 2 mg, 3 mg, and 5 mg. This regulatory green light enhances Biocon's expansive portfolio of vertically integrated drug products.

The Everolimus tablets are authorized for treating both adult and pediatric patients, aged one year and older, who suffer from Tuberous Sclerosis Complex with subependymal giant cell astrocytoma. Additionally, they are approved for adjunctive treatment in patients aged two years and above with TSC-associated partial-onset seizures.