Biocon Pharma Limited, a subsidiary of Biocon, has received approval from the U.S. Food and Drug Administration (FDA) for its ANDA for Everolimus Tablets for Oral Suspension in 2 mg, 3 mg, and 5 mg strengths. These tablets are indicated for treating adult and pediatric patients aged 1 year and older with Tuberous Sclerosis Complex (TSC) and other conditions. This approval strengthens Biocon’s vertically integrated drug portfolio.
FDA Approval for Everolimus Tablets
Biocon Pharma Limited announced that it has secured approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets intended for Oral Suspension. The tablets are available in 2 mg, 3 mg, and 5 mg strengths, expanding Biocon’s offerings in critical therapeutic areas.
Therapeutic Indication
Everolimus Tablets are indicated for the treatment of adult and pediatric patients aged 1 year and older diagnosed with Tuberous Sclerosis Complex (TSC). It also addresses Subependymal Giant Cell Astrocytoma (SEGA) and is used for the adjunctive treatment of adult and pediatric patients aged 2 years and older suffering from TSC-associated partial-onset seizures.
Portfolio Enhancement
The FDA approval is anticipated to substantially strengthen Biocon’s portfolio, furthering its capabilities in vertically integrated drug product offerings. The approval enables Biocon to address a significant unmet medical need, reinforcing its position in the market.
Source: BSE
