Biocon has received approval from the US Food and Drug Administration (USFDA) for its Everolimus tablets, marking a significant regulatory achievement for the Indian pharmaceutical company. The approval covers three different tablet strengths, providing healthcare providers with flexible dosing options for patient treatment.

Product Specifications and Strengths

The USFDA has approved Biocon's Everolimus tablets in the following specifications:

Therapeutic Applications

The approved Everolimus tablets are indicated for treating two specific medical conditions. Tuberous Sclerosis Complex represents a rare genetic disorder that causes non-malignant tumors to form in various organs throughout the body. The second indication covers Subependymal Giant Cell Astrocytomas (SEGAs), which are slow-growing brain tumors typically associated with Tuberous Sclerosis Complex.

Market Impact and Portfolio Expansion

This USFDA approval strengthens Biocon's position in the American pharmaceutical market, particularly in the oncology and rare disease segments. The multiple strength formulations provide physicians with dosing flexibility when treating patients with these specialized conditions. Everolimus belongs to a class of medications known as mTOR inhibitors, which work by blocking certain proteins that promote cell growth and division.

Regulatory Significance

Receiving USFDA approval represents a crucial milestone for pharmaceutical companies seeking to establish their presence in one of the world's largest healthcare markets. The approval process involves rigorous evaluation of safety, efficacy, and manufacturing quality standards. For Biocon, this achievement adds another product to its growing portfolio of US-approved medications and demonstrates the company's capability to meet stringent regulatory requirements for specialized therapeutic areas.

Biocon Limited has announced a significant regulatory milestone with its wholly owned subsidiary Biocon Pharma Limited receiving approval from the U.S. Food and Drug Administration (U.S. FDA) for Everolimus Tablets for Oral Suspension. The company notified stock exchanges about this development on January 12, 2026.

FDA Approval Details

The U.S. FDA has approved Biocon Pharma Limited's Abbreviated New Drug Application (ANDA) for Everolimus Tablets for Oral Suspension across three different strengths. The approval encompasses a comprehensive range of dosing options for healthcare providers.

Therapeutic Applications

The approved Everolimus Tablets for Oral Suspension serve specific medical indications related to Tuberous Sclerosis Complex (TSC). The medication addresses two distinct patient populations with different age requirements and treatment purposes.

Primary Indications:

• SEGA Treatment: For adult and pediatric patients aged 1 year and older with Tuberous Sclerosis Complex who have Subependymal Giant Cell Astrocytoma
• Seizure Management: For adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures

Strategic Impact

According to the company's notification to stock exchanges, this FDA approval will further strengthen Biocon's portfolio of vertically integrated drug products. The approval represents an expansion of the company's presence in the U.S. pharmaceutical market through its specialized oncology and rare disease treatment offerings.

The regulatory milestone demonstrates Biocon Pharma Limited's capability to successfully navigate the complex U.S. FDA approval process for specialized therapeutic products. This achievement adds to the company's growing portfolio of approved pharmaceutical products in international markets.