Biocon has informed that Biocon Pharma, a wholly owned subsidiary of the Company, has received approval from the U.S. Food and Drug Administration (U.S. FDA) 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 Biocon’s portfolio of vertically integrated drug products.
The above information is a part of company’s filings submitted to BSE.
