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Biocon Pharma Limited Receives U.S. FDA Approval for Everolimus Tablets for Oral Suspension

  • Mon, 12-Jan-2026
  • Posted by: BIOCON
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NOTIFICATION TO STOCK EXCHANGE

COMPANY STATEMENT

This is to inform you that Biocon Pharma Limited, 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.



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Author: BIOCON

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