Biocon’s arm gets USFDA nod for ANDA of Everolimus Tablets

12 Jan 2026 Evaluate

Biocon’s wholly owned subsidiary -- Biocon Pharma has secured approval from the U.S. Food and Drug Administration (USFDA) for its 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 pediatric patients aged 1 year and older with Tuberous Sclerosis Complex (TSC) who have Subependymal Giant Cell Astrocytoma (SEGA) and for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. The approval will further strengthen the company’s portfolio of vertically integrated drug products.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.

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