Biocon Pharma Limited, a wholly owned subsidiary of Biocon Limited, has received approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets for Oral Suspension. The approval covers 2 mg, 3 mg and 5 mg strengths.
Everolimus Tablets for Oral Suspension are indicated for the treatment of adult and pediatric patients aged one year and above diagnosed with Tuberous Sclerosis Complex (TSC) with Subependymal Giant Cell Astrocytoma (SEGA). The product is also approved as an adjunctive therapy for adult and pediatric patients aged two years and older for the treatment of TSC-associated partial-onset seizures.
This approval further strengthens Biocon Pharma’s portfolio in complex generics and reinforces its commitment to expanding access to affordable treatment options for patients with rare and chronic neurological conditions in the United States.
